Home / Recalls / Apotex Inc. / D-0316-2020

D-0316-2020 Class II

Recalled by Apotex Inc. — North York, N/A

Recall Details

Product Type
Drugs
Report Date
November 20, 2019
Initiation Date
September 24, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,132,453 bottles

Product Description

Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00

Reason for Recall

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

Distribution Pattern

Nationwide

Code Information

All lots remaining within expiry.

Other recalls by Apotex Inc.

  • D-0510-2026 Class II — Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, M (April 8, 2026)
  • D-0407-2026 Class II — Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx On (March 5, 2026)
  • D-0677-2025 Class II — Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufa (September 5, 2025)
  • D-0676-2025 Class II — Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and (September 5, 2025)
  • D-0494-2025 Class II — Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured b (May 28, 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-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)