Recalls / Class I
Class ID-0556-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Polymyxin B
- Generic name
- Polymyxin B
- Active ingredient
- Polymyxin B Sulfate
- Route
- Intramuscular, Intrathecal, Intravenous, Ophthalmic
- NDC
- 55150-234
- FDA application
- ANDA206589
- Affected lot / code info
- Lot CPB200013, exp 9/2022
Why it was recalled
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 35,520 vials
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2022-01-26
- FDA classified
- 2022-02-10
- Posted by FDA
- 2022-02-16
- Terminated
- 2024-08-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0556-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.