Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot CPB200013, exp 9/2022
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0556-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 26, 2022
- FDA report date
- Feb 16, 2022
- Quantity
- 35,520 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0556-2022, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89457
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot CPB200013, exp 9/2022
- Postal code
- 08520-1401
- Report date
- Feb 16, 2022
- Product type
- Drugs
- Recall number
- D-0556-2022
- Classification
- Class I
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 35,520 vials
- Termination date
- Aug 20, 2024
- Reason for recall
- Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Jan 26, 2022
- Initial firm notification
- Letter
- Center classification date
- Feb 10, 2022