Piperacillin and Tazobactam for Injection — Class I drug recall D-0840-2018
Terminated recall by Apotex Inc., reported 2018-05-23, distributed nationwide. Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
| Recall number | D-0840-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., North York, Canada |
| Recall initiated | 2018-05-08 |
| Classified | 2018-06-05 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2023-10-03 |
| Distributed | Nationwide (US) |
| Quantity | 13,453 vials |
| Reason classes | potency, specification failure |
| NDC | 60505-0688-04 |
| Lot numbers | 502H001, 502H003, 502H004, 502H005, 502H009, 502H012 |
| Expiration dates | 2019-01, 2019-04, 2019-05 |
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
Reason for recall
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0840-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.