FDAFDA · Food and drugs·Recall number D-0556-2022
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
Published February 16, 2022 · Recall initiated: January 26, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- POLYMYXIN B
- Manufacturer
- AuroMedics Pharma LLC
- Distributor
- Nationwide in the US
- UPC
- 0355150234103
- Lot
- Lot CPB200013, exp 9/2022
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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