AuroMedics Pharma LLC: Drug Recall
Recall #D-0556-2022 · 01/26/2022
Class I: Dangerous
Recall Details
- Recall Number
- D-0556-2022
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- AuroMedics Pharma LLC
- Status
- Terminated
- Date Initiated
- 01/26/2022
- Location
- East Windsor, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,520 vials
Reason for Recall
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
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
Distribution Pattern
Nationwide in the US
Other Recalls by AuroMedics Pharma LLC
- Class II: Risk 09/30/2022
- Class III: Low Risk 09/26/2022
- Class II: Risk 09/26/2022
- Class II: Risk 12/30/2020
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.