Zerbaxa — Class II drug recall D-0176-2021
Terminated recall by Merck Sharp & Dohme, reported 2021-01-13, distributed nationwide. Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specifi
| Recall number | D-0176-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merck Sharp & Dohme, Rahway, NJ, United States |
| Recall initiated | 2020-12-21 |
| Classified | 2021-01-07 |
| Reported by FDA | 2021-01-13 |
| Terminated | 2023-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 106,503 vials |
| Reason classes | sterility, specification failure |
| NDC | 67919-0030, 67919-0030-01 |
Product
Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., NDC 67919-030-01
Reason for recall
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
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-0176-2021. 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.