Reported Feb 16, 2022 · Terminated
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only,…
AuroMedics Pharma LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AuroMedics Pharma LLC · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401
Is this the product you have?
- Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only
- Distributed byAuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10
- Lot codes and dates
Lot CPB200013exp 9/2022
- Amount recalled
- 35,520 vials
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Using this product could cause serious injury, illness or death — stop using it now.
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