fda
193 records
FDA Drug Recall: Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, package
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes,
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by:
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed b
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Opera
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For I
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distribu
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Dis
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by:
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distri
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Dist
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, M
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by:
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count b
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intrav
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vi
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g,
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactur
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneou
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactur
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Steril
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Di
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, S
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL b
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL am
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only,
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured b
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distribu
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only,
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by:
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles,
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 4
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., L
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distribute
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tr
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscu
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distr
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Di
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactu
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cup
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by:
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL u
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, S
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by:
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed b
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Dist
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, R
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Sing
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufac
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Onl
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distribu
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distr
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx o
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bo
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distribute
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampule
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating C
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed b
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Oper
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Opera
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Dist
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, S
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distri
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by:
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufact
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TEC
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, R
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH P
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b)
2023-06-07
Class II — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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FDA Drug Recall: Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye
2023-02-15
Class III — Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
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FDA Drug Recall: Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufacture
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per droppe
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured b
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper b
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Ma
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manuf
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube,
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufac
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-do
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bo
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Relieve
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx o
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP,
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube,
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bot
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactu
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per t
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottl
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, M
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Ant
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bott
2023-01-25
Class II — CGMP Deviations:
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FDA Drug Recall: Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn
2022-10-05
Class II — Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
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FDA Drug Recall: Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-cou
2022-10-05
Class II — Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
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FDA Drug Recall: Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufacture
2022-09-14
Class II — cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
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FDA Drug Recall: Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube
2022-09-14
Class II — cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
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FDA Drug Recall: Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx
2022-09-07
Class III — Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.
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FDA Drug Recall: PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH
2022-08-24
Class II — Defective Container: Product has incomplete induction seals.
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FDA Drug Recall: Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber
2022-07-06
Class II — Defective container: defect prevents product from dispensing as intended.
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FDA Drug Recall: Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. o
2022-07-06
Class II — Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
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FDA Drug Recall: Olopatadine HCl, Ophthalmic Solution, USP, 0.2%, 2.5 mL per dropper bottle, Rx O
2022-07-06
Class III — Failed impurity/degradation specifications: Out of specification for 2-HMP (a product leachable) measured in retention samples
FDA Drug Recall: Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bott
2022-05-11
Class III — Failed viscosity specification - product was below specificcation
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FDA Drug Recall: TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 S
2022-03-30
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only
2022-01-19
Class III — Labeling: Missing Label
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FDA Drug Recall: Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottl
2022-01-19
Class III — Labeling: Missing Label
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FDA Drug Recall: Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and e
2022-01-19
Class II — Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
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FDA Drug Recall: Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL droppe
2021-10-13
Class II — Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
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FDA Drug Recall: Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL b
2021-09-22
Class II — Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
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FDA Drug Recall: Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per t
2021-09-08
Class II — Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Ba...
View Source
FDA Drug Recall: Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cu
2021-03-24
Class II — Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
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FDA Drug Recall: Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TE
2021-01-20
Class II — Defective container: Customer complaints for oral solution leaking from bottles.
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FDA Drug Recall: Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, D
2020-10-07
Class II — CGMP Deviations
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FDA Drug Recall: Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bot
2020-07-22
Class III — Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
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FDA Drug Recall: Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only,
2020-06-17
Class III — Discoloration: Out of Specification (OOS) result for APHA Color Test.
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FDA Drug Recall: Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton
2020-04-08
Class III — Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
View Source
FDA Drug Recall: Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Dist
2020-03-04
Class III — Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the ...
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FDA Drug Recall: CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed
2020-03-04
Class III — Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the ...
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FDA Drug Recall: Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akor
2020-03-04
Class III — Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the ...
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FDA Drug Recall: Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only
2020-02-19
Class II — Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
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FDA Drug Recall: MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x
2020-01-08
Class II — Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-c...
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FDA Drug Recall: Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx onl
2019-10-09
Class II — Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
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FDA Drug Recall: Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactur
2019-10-02
Class II — cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the...
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FDA Drug Recall: Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For I
2019-09-04
Class III — Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
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FDA Drug Recall: Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 1747
2019-09-04
Class III — Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
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FDA Drug Recall: Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For I
2019-09-04
Class III — Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impuri...
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FDA Drug Recall: Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules
2019-06-26
Class III — Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
View Source
FDA Drug Recall: Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton
2019-05-01
Class III — Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
View Source
FDA Drug Recall: Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only,
2019-04-10
Class III — Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
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FDA Drug Recall: Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx
2019-03-27
Class II — Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
View Source
FDA Drug Recall: Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufac
2019-03-20
Class II — Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time p...
View Source
FDA Drug Recall: Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b
2019-02-27
Class III — Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
View Source
FDA Drug Recall: Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ
2019-02-27
Class II — Failed Stability Specification: out of specification results for Sodium Perborate
View Source
FDA Drug Recall: COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Mal
2019-02-20
Class III — Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
View Source
FDA Drug Recall: Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only,
2019-02-06
Class II — Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
View Source
FDA Drug Recall: Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledge
2018-12-05
Class III — Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
View Source
FDA Drug Recall: Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For Ve
2018-09-12
Class II — Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
View Source
FDA Drug Recall: Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle pe
2018-09-05
Class III — Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
View Source
FDA Drug Recall: Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: H
2018-08-15
Class II — Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
View Source
FDA Drug Recall: Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akr
2018-07-18
Class II — CGMP Deviations
View Source
FDA Drug Recall: 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs
2018-04-04
Class III — Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
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FDA Drug Recall: 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs
2018-04-04
Class III — Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
View Source
FDA Drug Recall: Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-1
2018-04-04
Class III — Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
View Source
FDA Drug Recall: Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: Ve
2018-03-28
Class III — Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
View Source
FDA Drug Recall: Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only,
2018-03-14
Class III — Failed Stability Specification: OOS low viscosity results discovered during retain testing.
View Source
FDA Drug Recall: Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottl
2018-01-17
Class III — CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
View Source
FDA Drug Recall: Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhex
2017-08-23
Class III — Crystallization with subpotent out of specification assay results for chlorhexidine.
View Source
FDA Drug Recall: Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup
2017-08-23
Class III — Crystallization with subpotent out of specification assay results for chlorhexidine.
View Source
FDA Drug Recall: Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhex
2017-08-23
Class III — Crystallization with subpotent out of specification assay results for chlorhexidine.
View Source
FDA Drug Recall: IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit contai
2017-05-17
Class III — Product is being recalled due to low pH value.
View Source
FDA Drug Recall: Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL ,
2017-05-10
Class II — Failed Dissolution Specifications
View Source
FDA Drug Recall: LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bott
2017-04-19
Class II — Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
View Source
FDA Drug Recall: Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g
2016-11-30
Class II — Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
View Source
FDA Drug Recall: Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn,
2016-11-09
Class II — Subpotent Drug: concentration of product is less than labeled amount.
View Source
FDA Drug Recall: Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Mar
2016-08-31
Class III — Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
View Source
FDA Drug Recall: Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bott
2016-06-08
Class II — Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
View Source
FDA Drug Recall: Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET b
2016-06-01
Class II — Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
View Source
FDA Drug Recall: PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (47
2016-06-01
Class II — Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
View Source
FDA Drug Recall: ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 m
2016-06-01
Class II — Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
View Source
FDA Drug Recall: Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4
2016-05-11
Class II — Presence of Particulate Matter
View Source
FDA Drug Recall: Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%
2015-11-25
Class III — Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." ...
View Source
FDA Drug Recall: RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake F
2015-11-25
Class III — Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
View Source
FDA Drug Recall: IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UP
2015-09-23
Class III — Subpotent Drug: Low out-of-specification potency result of the drug product.
View Source
FDA Drug Recall: Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bott
2015-06-17
Class II — Failed Impurities/Degradation Specifications
View Source
FDA Drug Recall: Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bott
2015-06-17
Class II — Failed Impurities/Degradation Specifications
View Source
FDA Drug Recall: SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, G
2015-05-20
Class II — Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
View Source
FDA Drug Recall: SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GR
2015-05-20
Class II — Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
View Source
FDA Drug Recall: SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CH
2015-05-20
Class II — Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
View Source
FDA Drug Recall: Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottl
2015-03-11
Class II — Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
View Source
FDA Drug Recall: Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kan
2015-02-18
Class II — Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
View Source
FDA Drug Recall: Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60
2015-01-14
Class III — Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
View Source
FDA Drug Recall: Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vi
2014-10-01
Class III — Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
View Source
fda_adverse
1 records
ftc
1 records
ftc_enforcement
1 records
Akorn, Inc., In the Matter of
2014-09-19
FTC live enforcement action FY2014; matched respondent 'Akorn, Inc., In the Matter of'
View Source
lobbying
1 records
Lobbying Client: AKORN, INC.
Lobbied by GOVERNMENT COUNSEL, LLC — pharmaceutical manufacturing
View Source
ny_corps
1 records
NY Corp: AKORN INC
2017-05-24
DOMESTIC BUSINESS CORPORATION | County: Kings | Jurisdiction: New York
View Source
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