Class I
Terminated
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
- Company
- Auromedics Pharma Llc
- Recall Initiated
- January 26, 2022
- Posted
- February 16, 2022
- Recall Number
- D-0556-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 35,520 vials
- Firm Location
- East Windsor, NJ, United States
Reason for Recall
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Distribution
Nationwide in the US
Lot / Code Info
Lot CPB200013, exp 9/2022
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