CourtListener
1 records
Court Opinion: Apotex, Inc. v. Senju Pharmaceutical Co.
2013-02-07
District Court, D. Delaware | Docket: Civ. No. 12-196-SLR | Cited 3x
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fda
74 records
FDA Recall: Apotex Corp. — Class II
20260422
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners. | Product: Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only,...
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FDA Drug Recall: Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx On
2026-03-25
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and
2025-10-08
Class II — Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
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FDA Drug Recall: Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufa
2025-10-08
Class II — Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
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FDA Drug Recall: Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured b
2025-07-02
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by:
2025-07-02
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx O
2025-07-02
Class II — Lack of Assurance of Sterility
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FDA Drug Recall: Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apote
2025-06-11
Class II — Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
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FDA Drug Recall: Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fil
2024-02-28
Class II — CGMP Deviations: potential presence of Burkholderia cepacia complex
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FDA Drug Recall: Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 6
2023-12-06
Class II — Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
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FDA Drug Recall: Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#:
2023-12-06
Class II — Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
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FDA Drug Recall: Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:
2023-12-06
Class II — Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
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FDA Drug Recall: Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60
2023-12-06
Class II — Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
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FDA Drug Recall: Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Uni
2023-05-17
Class II — Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
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FDA Drug Recall: Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dr
2023-03-15
Class II — Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
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FDA Drug Recall: Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex I
2023-01-04
Class III — Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
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FDA Drug Recall: Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2
2022-07-27
Class II — Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
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FDA Drug Recall: Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex
2022-05-25
Class III — Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
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FDA Drug Recall: Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufacture
2021-04-14
Class II — Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
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FDA Drug Recall: Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic S
2021-02-17
Class I — Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
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FDA Drug Recall: Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automa
2021-02-17
Class I — Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
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FDA Drug Recall: Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 6
2020-11-25
Class II — Failed Dissolution Specifications: Out of specification for dissolution.
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FDA Drug Recall: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles,
2020-06-24
Class II — CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
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FDA Drug Recall: Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets
2019-11-20
Class II — GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
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FDA Drug Recall: Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Ta
2019-11-20
Class II — GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
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FDA Drug Recall: Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid
2019-11-20
Class II — GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
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FDA Drug Recall: Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer D
2019-11-20
Class II — GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
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FDA Drug Recall: Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer
2019-11-20
Class II — GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
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FDA Drug Recall: Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reduc
2019-11-20
Class II — GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
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FDA Drug Recall: Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufact
2019-11-06
Class III — Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
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FDA Drug Recall: Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Bliste
2019-03-13
Class II — Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
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FDA Drug Recall: Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 12
2018-06-13
Class II — Presence of foreign substance: glass particles
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FDA Drug Recall: Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Us
2018-05-23
Class I — Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
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FDA Drug Recall: Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single
2018-05-23
Class I — Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
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FDA Drug Recall: CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Ap
2017-03-01
Class II — Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
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FDA Drug Recall: Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex In
2017-02-15
Class III — Superpotent Drug: Product may not meet specifications throughout shelf life.
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FDA Drug Recall: Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc.,
2017-01-11
Class II — CGMP Deviations
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FDA Drug Recall: Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc.
2017-01-11
Class II — CGMP Deviations
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FDA Drug Recall: Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-059
2015-10-21
Class II — Lack of Assurance of Sterility: Failed preservative effectiveness testing
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FDA Drug Recall: Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles
2015-10-07
Class III — Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
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FDA Drug Recall: Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count
2015-09-23
Class II — Failed Stability Specifications: product may not meet specification limit for assay test.
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FDA Drug Recall: Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottl
2015-07-15
Class II — Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
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FDA Drug Recall: Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured f
2015-07-15
Class II — Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
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FDA Drug Recall: Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured f
2015-07-15
Class II — Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
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FDA Drug Recall: Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured fo
2015-07-15
Class II — Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
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FDA Drug Recall: Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manu
2015-05-20
Class III — Subpotent drug
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FDA Drug Recall: Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-
2015-05-20
Class III — Subpotent drug
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FDA Drug Recall: Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3
2015-05-20
Class III — Subpotent drug
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FDA Drug Recall: Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL,
2015-04-22
Class III — CGMP Deviations: Product excipient was not re-tested at the appropriate date.
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FDA Drug Recall: Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by A
2014-11-12
Class III — Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
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FDA Drug Recall: Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 9
2014-11-12
Class III — Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
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FDA Drug Recall: Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 9
2014-11-12
Class III — Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
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FDA Drug Recall: Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by A
2014-11-12
Class III — Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
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FDA Drug Recall: Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufac
2014-10-01
Class III — Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
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FDA Drug Recall: Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bo
2014-09-24
Class III — Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
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FDA Drug Recall: Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manuf
2014-09-10
Class II — Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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FDA Drug Recall: PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by
2014-09-10
Class II — Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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FDA Drug Recall: PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by
2014-09-10
Class II — Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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FDA Drug Recall: PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, R
2014-09-10
Class II — Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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FDA Drug Recall: Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Man
2014-09-10
Class II — Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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FDA Drug Recall: PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx
2014-09-10
Class II — Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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FDA Drug Recall: PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Man
2014-09-10
Class II — Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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FDA Drug Recall: PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by
2014-09-10
Class II — Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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FDA Drug Recall: Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Man
2014-09-10
Class II — Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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FDA Drug Recall: Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apote
2014-05-07
Class III — Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
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FDA Drug Recall: Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apot
2013-12-04
Class II — Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
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FDA Drug Recall: Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Pac
2013-08-14
Class I — Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
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FDA Drug Recall: Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only
2013-08-14
Class II — Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.
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FDA Drug Recall: Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Pac
2013-07-24
Class I — Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
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FDA Drug Recall: Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count
2012-09-05
Class II — Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
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FDA Drug Recall: Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex
2012-09-05
Class II — Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
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FDA Drug Recall: Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered S
2012-09-05
Class III — CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
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FDA Drug Recall: Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by:
2012-08-15
Class II — Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
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FDA Drug Recall: Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bo
2012-08-08
Class II — Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
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fda_adverse
2 records
FDA AE Manufacturer: Apotex Corp
Drug adverse event reporter — Product: PAROXETINE HYDROCHLORIDE
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lobbying
4 records
Lobbying Firm: APOTEX CORP.
Registered lobbying firm — WESTON, FL — Generic pharmaceutical manufacturer
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Lobbying Client: APOTEX, CORP.
Lobbied by KOUNTOUPES DENHAM CARR & REID, LLC — Generic pharmaceutical manufacturer.
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Lobbying Client: APOTEX, CORP.
Lobbied by KOUNTOUPES DENHAM CARR & REID, LLC — Generic pharmaceutical manufacturer.
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ny_corps
1 records
NY Corp: APOTEX CORP.
2020-12-23
FOREIGN BUSINESS CORPORATION | County: Westchester | Jurisdiction: Delaware
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