Apotex Inc. recalls

25 recalls on record · latest: May 27, 2020

Official U.S. recall history for Apotex Inc., compiled from official government records.

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Metformin Hydrochloride Extended-Release Tablets recalled over manufacturing violations

May 27, 2020 · Drug & medication recalls Moderate risk CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity a…

Apotex Inc. recalls Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario C…

October 22, 2019 · Drug & medication recalls Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg foun…

Apotex Inc. recalls Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Be…

September 24, 2019 · Drug & medication recalls Moderate risk GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (N…

Apotex Inc. recalls Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-…

September 24, 2019 · Drug & medication recalls Moderate risk GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (N…

Apotex Inc. recalls Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 1182…

September 24, 2019 · Drug & medication recalls Moderate risk GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (N…

Apotex Inc. recalls Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane…

September 24, 2019 · Drug & medication recalls Moderate risk GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (N…

Apotex Inc. recalls Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distribute…

September 24, 2019 · Drug & medication recalls Moderate risk GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (N…

Apotex Inc. recalls Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wi…

September 24, 2019 · Drug & medication recalls Moderate risk GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (N…

Apotex Inc. recalls Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged a…

March 1, 2019 · Drug & medication recalls Moderate risk Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.

Apotex Inc. recalls Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill…

May 31, 2018 · Drug & medication recalls Moderate risk Presence of foreign substance: glass particles

Apotex Inc. recalls Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: H…

May 8, 2018 · Drug & medication recalls High risk Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Apotex Inc. recalls Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by:…

May 8, 2018 · Drug & medication recalls High risk Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Apotex Inc. recalls CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M…

February 3, 2017 · Drug & medication recalls Moderate risk Failed Impurities/Degradations Specifications; out of specification results for…

Apotex Inc. recalls Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9;…

December 19, 2016 · Drug & medication recalls Superpotent Drug: Product may not meet specifications throughout shelf life.

Bromfenac Ophthalmic Solution 0 recalled over sterility concerns

August 25, 2015 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: Failed preservative effectiveness testing

Apotex Inc. recalls Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex…

August 17, 2015 · Drug & medication recalls Moderate risk Failed Stability Specifications: product may not meet specification limit for a…

Apotex Inc. recalls Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by…

July 21, 2015 · Drug & medication recalls Failed Dissolution Specification: One lot of product did not meet the first sta…

Apotex Inc. recalls Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc…

May 29, 2015 · Drug & medication recalls Moderate risk Failed Content Uniformity Specifications: The product may not meet the limit fo…

Apotex Inc. recalls Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1…

May 29, 2015 · Drug & medication recalls Moderate risk Failed Content Uniformity Specifications: The product may not meet the limit fo…

Apotex Inc. recalls Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1…

May 29, 2015 · Drug & medication recalls Moderate risk Failed Content Uniformity Specifications: The product may not meet the limit fo…

Apotex Inc. recalls Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T…

May 29, 2015 · Drug & medication recalls Moderate risk Failed Content Uniformity Specifications: The product may not meet the limit fo…

Apotex Inc. recalls Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontari…

April 7, 2015 · Drug & medication recalls Subpotent drug

Apotex Inc. recalls Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 605…

April 7, 2015 · Drug & medication recalls Subpotent drug

Apotex Inc. recalls Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 6050…

April 7, 2015 · Drug & medication recalls Subpotent drug

Bromfenac Ophthalmic Solution 0 recalled over manufacturing violations

February 12, 2015 · Drug & medication recalls CGMP Deviations: Product excipient was not re-tested at the appropriate date.