Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 10, 2014DrugsFDA
Apotex Inc. recalls Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27
Hazard: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
September 10, 2014DrugsFDA
Apotex Inc. recalls Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 2770
Hazard: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
September 10, 2014DrugsFDA
Apotex Inc. recalls PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27
Hazard: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
September 10, 2014DrugsFDA
Apotex Inc. recalls Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27
Hazard: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
May 7, 2014DrugsFDA
Apotex Inc. recalls Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9
Hazard: Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
December 4, 2013DrugsFDA
Apotex Inc. recalls Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T
Hazard: Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
August 14, 2013DrugsFDA
Apotex Inc recalls Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto,
Hazard: 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.
August 14, 2013DrugsFDA
Apotex Corp. recalls Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Hea
Hazard: Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
July 24, 2013DrugsFDA
Apotex Corp. recalls Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Hea
Hazard: Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
September 5, 2012DrugsFDA
Apotex Corp. recalls Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., To
Hazard: CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
September 5, 2012DrugsFDA
Apotex Corp. recalls Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex I
Hazard: Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
September 5, 2012DrugsFDA
Apotex Corp. recalls Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Man
Hazard: Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
August 15, 2012DrugsFDA
Apotex Corp. recalls Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076
Hazard: Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
August 8, 2012DrugsFDA
Apotex Inc. recalls Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye
Hazard: Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.