Home / Recalls / Apotex Inc. / D-1303-2020

D-1303-2020 Class II

Recalled by Apotex Inc. — North York

Recall Details

Product Type
Drugs
Report Date
June 24, 2020
Initiation Date
May 27, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
305,963 bottles

Product Description

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1

Reason for Recall

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels

Distribution Pattern

Nationwide.

Code Information

All lots remaining within expiry

Other recalls by Apotex Inc.

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  • D-0676-2025 Class II — Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and (September 5, 2025)
  • D-0677-2025 Class II — Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufa (September 5, 2025)
  • D-0495-2025 Class II — Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: (May 28, 2025)
  • D-0496-2025 Class II — Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx O (May 28, 2025)
  • D-0457-2025 Class II — Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apote (May 28, 2025)
  • D-0494-2025 Class II — Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured b (May 28, 2025)
  • D-0326-2024 Class II — Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fil (February 9, 2024)
  • D-0121-2024 Class II — Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 6 (November 1, 2023)