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
Reported: February 16, 2022 Initiated: January 26, 2022 #D-0556-2022
Product Description
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
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 35,520 vials
- Distribution
- Nationwide in the US
- Location
- East Windsor, NJ
Frequently Asked Questions
What product 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. Recalled by AuroMedics Pharma LLC. Units affected: 35,520 vials.
Why was this product recalled? ▼
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 16, 2022. Severity: Critical. Recall number: D-0556-2022.
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