Polymyxin B for Injection USP recall: Particulate Matter
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
Why was Polymyxin B for Injection USP recalled?
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot CPB200013, exp 9/2022
- Product
- 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
- Recalling firm
- AuroMedics Pharma LLC
- Quantity
- 35,520 vials
- Distribution
- Nationwide in the US
- Recall date
- February 16, 2022
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)