Piperacillin and Tazobactam for Injection — Class I drug recall D-0839-2018
Terminated recall by Apotex Inc., reported 2018-05-23, distributed nationwide. Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
| Recall number | D-0839-2018 |
|---|---|
| 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 | 121,693 vials |
| Reason classes | potency, specification failure |
| NDC | 60505-0687-04 |
| Lot numbers | 501G014, 501G015, 501G016, 501G017, 501G018, 501G019, 501G020, 501G021, 501G022, 501G023, 501G024, 501G025, 501G026, 501G027, 501G028, 501G029, 501G030, 501H001, 501H002, 501H003, 501H004, 501H005, 501H006, 501H007, 501H008, 501H009, 501H012, 501H013, 501H018, 501H019 |
| Expiration dates | 2018-05, 2018-09, 2018-10, 2018-11, 2018-12, 2019-04, 2019-06, 2019-09 |
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
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-0839-2018. 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.