Why it was recalled
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Product description
PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05
Lot numbers, UPCs & expiration codes
Lots: BH2003A, Exp. 8/19/2022; BH2011A, Exp. 11/9/2022
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-1346-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 10, 2022
- FDA report date
- Aug 24, 2022
- Quantity
- 2030 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Sterile Compounding Center LLC
Original FDA data
Every field from FDA enforcement report D-1346-2022, exactly as published.
Show all FDA fields
- City
- West Columbia
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 90718
- Address
- 4500 12th Street Ext
- Code information
- Lots: BH2003A, Exp. 8/19/2022; BH2011A, Exp. 11/9/2022
- Postal code
- 29172-3025
- Report date
- Aug 24, 2022
- Product type
- Drugs
- Recall number
- D-1346-2022
- Classification
- Class II
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Product quantity
- 2030 bags
- Termination date
- Oct 11, 2024
- Reason for recall
- CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 10, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2022