Apotex Recalls
76 recalls on record in the United States
Apotex Corp. recalls Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
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Apotex Corp. recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx O
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
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Apotex Corp. recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx
Lack of Assurance of Sterility
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Apotex Corp. recalls Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Onl
Lack of Assurance of Sterility
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Apotex Corp. recalls Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.
Lack of Assurance of Sterility
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Apotex Corp. recalls Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Ma
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
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Apotex Corp. recalls Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered S
CGMP Deviations: potential presence of Burkholderia cepacia complex
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Apotex Corp. recalls Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-c
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
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Apotex Corp. recalls Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
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Apotex Corp. recalls Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
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Apotex Corp. recalls Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-c
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
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Apotex Corp. recalls Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP C
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
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Apotex Corp. recalls Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Pac
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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Apotex Corp. recalls Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx On
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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Apotex Corp. recalls Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
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Apotex Corp. recalls Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Man
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
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Apotex Corp. recalls Guanfacine Extended-Release Tablets 2 mg,100-count bottles,
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
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Apotex Corp. recalls Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syrin
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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Apotex Corp. recalls Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose
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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Apotex Corp. recalls Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000
Failed Dissolution Specifications: Out of specification for dissolution.
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Apotex Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
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Apotex Inc. recalls Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
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Apotex Inc. recalls Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
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Apotex Inc. recalls Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 1
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
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Apotex Inc. recalls Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 1
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
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Apotex Inc. recalls Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, US
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
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Apotex Inc. recalls Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, U
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
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Apotex Inc. recalls Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottle
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
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Apotex Inc. recalls Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 m
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
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Apotex Inc. recalls Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in
Presence of foreign substance: glass particles
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Showing 30 of 76 recalls. See all →