Drug 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
D-0556-2022
Product summary
- Event
- Event 89457
- Status
- Terminated
- Classification
- Class I
- Quantity
- 35,520 vials
- Official record key
drug-enforcement:D-0556-2022
Official wording
Reason: Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Code information: Lot CPB200013, exp 9/2022
Distribution pattern: Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter