Meropenem for Injection — Class II drug recall D-0095-2019
Terminated recall by Pfizer Inc., reported 2018-10-31, distributed nationwide. Lack of assurance of sterility: loss of container integrity.
| Recall number | D-0095-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2018-09-20 |
| Classified | 2018-10-24 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2022-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 71,075 vials |
| Reason classes | sterility |
| NDC | 00409-3506-01, 00409-3506-11 |
| Lot numbers | 609G047 |
| Expiration dates | 2018-10 |
Product
Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11
Reason for recall
Lack of assurance of sterility: loss of container integrity.
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-0095-2019. 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.