Ampicillin and Sulbactam for Injection 1 — Class I drug recall D-0339-2018
Terminated recall by Aurobindo Pharma Ltd., reported 2018-02-14, distributed nationwide. Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particula
| Recall number | D-0339-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma Ltd., Hyderabad, N/A, India |
| Recall initiated | 2018-01-02 |
| Classified | 2018-02-08 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2019-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 53,040 vials |
| Reason classes | foreign material, specification failure |
| NDC | 55150-0116, 55150-0116-20, 55150-0117, 55150-0117-20, 55150-0178, 55150-0178-99, 55150-0179, 55150-0179-99 |
| Lot numbers | AF0117001-A |
Product
Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20
Reason for recall
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
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-0339-2018. 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.