Unasyn — Class II drug recall D-1306-2020
Terminated recall by Pfizer Inc., reported 2020-06-17, distributed nationwide. Presence of Particulate Matter: particulate matter identified after reconstitution.
| Recall number | D-1306-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2020-05-29 |
| Classified | 2020-06-12 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2022-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 94,320 units |
| Reason classes | specification failure |
| NDC | 00049-0013, 00049-0013-81, 00049-0013-83, 00049-0014, 00049-0014-81, 00049-0014-83, 00049-0710, 00049-0710-01, 00049-0710-10, 00049-3003, 00049-3003-01, 00049-3003-10 |
| Lot numbers | 3301612 |
| Expiration dates | 2022-02 |
Product
Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83
Reason for recall
Presence of Particulate Matter: particulate matter identified after reconstitution.
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-1306-2020. 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.