Why it was recalled
CGMP Deviations: Potential for cross contamination due to product carry over.
Product description
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.
Lot numbers, UPCs & expiration codes
Lots: NE1062A, NE1062B Exp. 12/02/2022; NE1065A, NE1065B Exp. 12/13/2022; NE2011A, NE2011B Exp. 03/15/2022.
Where it was sold
Nationwide in the USA
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-0065-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 10, 2022
- FDA report date
- Nov 23, 2022
- Quantity
- 56,220 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Sterile Compounding Center LLC
Original FDA data
Every field from FDA enforcement report D-0065-2023, exactly as published.
Show all FDA fields
- City
- West Columbia
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 91132
- Address
- 4500 12th Street Ext
- Code information
- Lots: NE1062A, NE1062B Exp. 12/02/2022; NE1065A, NE1065B Exp. 12/13/2022; NE2011A, NE2011B Exp. 03/15/2022.
- Postal code
- 29172-3025
- Report date
- Nov 23, 2022
- Product type
- Drugs
- Recall number
- D-0065-2023
- Classification
- Class II
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Product quantity
- 56,220 vials
- Termination date
- Sep 24, 2024
- Reason for recall
- CGMP Deviations: Potential for cross contamination due to product carry over.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 10, 2022
- Initial firm notification
- Letter
- Center classification date
- Nov 17, 2022