Polymyxin B for Injection USP — Class I drug recall D-0556-2022
Terminated recall by AuroMedics Pharma LLC, reported 2022-02-16, distributed nationwide. Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
| Recall number | D-0556-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2022-01-26 |
| Classified | 2022-02-10 |
| Reported by FDA | 2022-02-16 |
| Terminated | 2024-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 35,520 vials |
| Reason classes | specification failure |
| NDC | 55150-0234, 55150-0234-10 |
| Lot numbers | CPB200013 |
| Expiration dates | 2022-09 |
Product
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10
Reason for recall
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
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-0556-2022. 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.