Ampicillin and Sulbactam for Injection — Class II drug recall D-0595-2023
Terminated recall by Astral SteriTech Private Ltd., reported 2023-05-24, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0595-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Astral SteriTech Private Ltd., Vadodara, N/A, India |
| Recall initiated | 2023-05-15 |
| Classified | 2023-05-18 |
| Reported by FDA | 2023-05-24 |
| Terminated | 2024-04-05 |
| Distributed | Nationwide (US) |
| Quantity | 357,550 vials |
| Reason classes | sterility |
| NDC | 66794-0206-41 |
Product
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-206-41
Reason for recall
Lack of Assurance of Sterility
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-0595-2023. 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.