Home / Recalls / Apotex Inc. / D-0840-2018

D-0840-2018 Class I Terminated

Recalled by Apotex Inc. — North York

Recall Details

Product Type
Drugs
Report Date
May 23, 2018
Initiation Date
May 8, 2018
Termination Date
October 3, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13453 vials

Product Description

Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4

Reason for Recall

Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Distribution Pattern

Nationwide in the USA.

Code Information

Lots: 502H001 Exp. 01/2019; 502H003, 502H004, 502H005, Exp. 04/2019; 502H009, 502H012, Exp. 05/2019.

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  • D-0495-2025 Class II — Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: (May 28, 2025)
  • D-0494-2025 Class II — Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured b (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-0496-2025 Class II — Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx O (May 28, 2025)
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  • D-0120-2024 Class II — Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#: (November 1, 2023)