Why it was recalled
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Product description
Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04
Lot numbers, UPCs & expiration codes
Lots: TC2007D, Exp. 8/26/2022; TC2010A, Exp. 9/25/2022
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-1345-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 10, 2022
- FDA report date
- Aug 24, 2022
- Quantity
- 294 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Sterile Compounding Center LLC
Original FDA data
Every field from FDA enforcement report D-1345-2022, 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: TC2007D, Exp. 8/26/2022; TC2010A, Exp. 9/25/2022
- Postal code
- 29172-3025
- Report date
- Aug 24, 2022
- Product type
- Drugs
- Recall number
- D-1345-2022
- Classification
- Class II
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Product quantity
- 294 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
- Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 10, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 16, 2022