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

FDA recall notice · announced February 16, 2022 · Auromedics Pharma

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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

Notes

Distribution: Nationwide in the US
Lot/code information: Lot CPB200013, exp 9/2022
Quantity: 35,520 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.