AuroMedics Pharma LLC recalls Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only,…
- Recall date
- January 26, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0556-2022
- FDA classification
- Class I
- Brand / firm
- AuroMedics Pharma LLC
- Sold / distributed
- Nationwide in the US
Why it was recalled
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
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
Get recall alerts
Free email alert whenever AuroMedics Pharma LLC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: AuroMedics Pharma LLC