Drug product
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
D-0840-2018
Product summary
- Firm
- Apotex Inc.
- Event
- Event 80063
- Status
- Terminated
- Classification
- Class I
- Quantity
- 13453 vials
- Official record key
drug-enforcement:D-0840-2018
Official wording
Reason: Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Code information: Lots: 502H001 Exp. 01/2019; 502H003, 502H004, 502H005, Exp. 04/2019; 502H009, 502H012, Exp. 05/2019.
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Subpotent