Department of Justice
1 records
DOJ: U.S. Compounding, Inc. Pleads Guilty To Multiple Fraud Offenses And Company Vice President Indicted In Scheme To Distribute Drugs Nationally Using Fal
2024-07-09
...subsidiary of DMK Pharmaceuticals Corporation, pled guilty to multiple fraud offenses...subsidiary of DMK Pharmaceuticals Corporation, pled guilty to multiple fraud offenses...prescriptions is wron...
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fda
65 records
FDA Drug Recall: Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx onl
2021-01-20
Class III — Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
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FDA Drug Recall: Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/
2021-01-06
Class III — Labelling: Missing label.
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FDA Drug Recall: Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compoundin
2019-02-27
Class II — Lack of assurance of sterility.
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FDA Drug Recall: LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL
2019-02-20
Class II — Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
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FDA Drug Recall: Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 m
2016-12-28
Class I — Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
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FDA Drug Recall: HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx o
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injecti
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 m
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compoun
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use,
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional I
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injectio
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Inject
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Voriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmi
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For top
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM Injec
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use, Rx only, Co
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topic
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Triamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regiona
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx onl
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Inj
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Tri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alpro
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper Fo
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded b
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL, Cy
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: ePHEDrine Sulfate PF (50 mg/10 mL), 10 mL Single-Use Syringe, For IV or IM Use
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injectio
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Trace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injecti
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topi
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Dapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra-Ar
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injecti
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use,
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL M
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL), Fo
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-Art
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx only
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx o
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophth
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Testosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM Injec
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection, Rx
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx onl
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-Arti
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical ophth
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL USP
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injecti
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT Inje
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injectio
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Com
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Inje
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: MIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounde
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Regio
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regio
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: MethylPREDNISolone PF (80 mg/mL), 1 mL Single Use Vial, For IM & Regional Inject
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC inject
2015-11-25
Class II — Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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FDA Drug Recall: ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe,
2014-08-27
Class II — Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL...
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nppes
1 records
ny_corps
1 records
NY Corp: US COMPOUNDING, INC.
2014-09-19
FOREIGN BUSINESS CORPORATION | County: Broome | Jurisdiction: Arkansas
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