FDA Drug recall D-0556-2022
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: Auro…
- FDA Drug
- Class I
- terminated
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class I recall of Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: Auro… by Auromedics Pharma, citing presence of Particulate Matter; product complaint of hair discovered in a vial within the lot.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0556-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-01-26 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Auromedics Pharma |
| Distribution | US |
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
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Identifiers
| ndc | 55150-234-10 |
|---|---|
| code_info | Lot CPB200013, exp 9/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0556-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.