Ampicillin and Sulbactam for Injection — Class I drug recall D-0866-2018
Terminated recall by AuroMedics Pharma LLC, reported 2018-05-16, distributed nationwide. Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believ
| Recall number | D-0866-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2018-05-01 |
| Classified | 2018-06-14 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2024-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 54,720 vials |
| Reason classes | 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 | AS0317035-A, AS0317041-A |
| Expiration dates | 2019-08-20 |
Product
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.
Reason for recall
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
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-0866-2018. 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.