FDA Recall D-0556-2022
AuroMedics Pharma LLC · East Windsor, NJ
Class I — life-threatening Terminated 937 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-0556-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the US
- Recall initiated
- 2022-01-26
- Classified by FDA Center
- 2022-02-10
- FDA published
- 2022-02-16
- Terminated
- 2024-08-20
- Recalling firm
- AuroMedics Pharma LLC
- Firm location
- East Windsor, NJ
Drug identification
- Brand name(s)
- POLYMYXIN B
- Generic name(s)
- POLYMYXIN B
- Manufacturer(s)
- Eugia US LLC
- NDC(s)
55150-234- Route(s)
- INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS, OPHTHALMIC