Apotex recalls

Apotex appears in 76 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Bromfenac Ophthalmic Solution 0.09%, Rx Only
  FDA Drug · Class III · 2015-04-22 · Apotex
  Reason: CGMP Deviations: Product excipient was not re-tested at the appropriate date.
• Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by…
  FDA Drug · Class III · 2014-11-12 · Apotex
  Reason: Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
• Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt
  FDA Drug · Class III · 2014-11-12 · Apotex
  Reason: Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
• Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt
  FDA Drug · Class III · 2014-11-12 · Apotex
  Reason: Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
• Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by…
  FDA Drug · Class III · 2014-11-12 · Apotex
  Reason: Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
• Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc
  FDA Drug · Class III · 2014-10-01 · Apotex
  Reason: Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
• Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt
  FDA Drug · Class III · 2014-09-24 · Apotex
  Reason: Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
• Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for…
  FDA Drug · Class II · 2014-09-10 · Apotex
  Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
• PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manuf…
  FDA Drug · Class II · 2014-09-10 · Apotex
  Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
• PAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Cor…
  FDA Drug · Class II · 2014-09-10 · Apotex
  Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
• Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured f…
  FDA Drug · Class II · 2014-09-10 · Apotex
  Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
• Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured f…
  FDA Drug · Class II · 2014-09-10 · Apotex
  Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
• PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709
  FDA Drug · Class II · 2014-09-10 · Apotex
  Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
• PAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Cor…
  FDA Drug · Class II · 2014-09-10 · Apotex
  Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
• PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Man…
  FDA Drug · Class II · 2014-09-10 · Apotex
  Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
• PAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Cor…
  FDA Drug · Class II · 2014-09-10 · Apotex
  Reason: Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
• Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for…
  FDA Drug · Class III · 2014-05-07 · Apotex
  Reason: Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
• Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for…
  FDA Drug · Class II · 2013-12-04 · Apotex
  Reason: Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
• Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt
  FDA Drug · Class I · 2013-08-14 · Apotex
  Reason: Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
• Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L…
  FDA Drug · Class II · 2013-08-14 · Apotex
  Reason: 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.
• Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt
  FDA Drug · Class I · 2013-07-24 · Apotex
  Reason: Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
• Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apote…
  FDA Drug · Class II · 2012-09-05 · Apotex
  Reason: Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
• Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontar…
  FDA Drug · Class II · 2012-09-05 · Apotex
  Reason: Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
• Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Can…
  FDA Drug · Class III · 2012-09-05 · Apotex
  Reason: CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
• Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactur…
  FDA Drug · Class II · 2012-08-15 · Apotex
  Reason: Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
• Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmi…
  FDA Drug · Class II · 2012-08-08 · Apotex
  Reason: Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.