Recall Enforment Report D-0839-2018
Recall Details
Multi event Drug Recall Enforcement Report Class I voluntary initiated by Apotex Inc., originally initiated on 05-08-2018 for the product Piperacillin and Tazobactam for Injection, USP 3.375 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 60505-0687-4 The product was recalled due to subpotent drug: high levels of impurities resulting in decrease potency. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0839-2018 | 05-08-2018 | 05-23-2018 | Class I | 121693 vials | Piperacillin and Tazobactam for Injection, USP 3.375 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 60505-0687-4 | Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency | Terminated |
| D-0840-2018 | 05-08-2018 | 05-23-2018 | Class I | 13453 vials | 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 | Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency | Terminated |
