Why it was recalled
CGMP Deviations: potential for trace amounts of product carryover.
Product description
Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.
Lot numbers, UPCs & expiration codes
Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024
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-0178-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 12, 2023
- FDA report date
- Feb 1, 2023
- Quantity
- 389,730 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Sc Inc
Original FDA data
Every field from FDA enforcement report D-0178-2023, exactly as published.
Show all FDA fields
- City
- West Columbia
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 91449
- Address
- 4500 12th Street Ext
- Code information
- Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024
- Postal code
- 29172-3025
- Report date
- Feb 1, 2023
- Product type
- Drugs
- Recall number
- D-0178-2023
- Classification
- Class II
- Recalling firm
- Nephron Sc Inc
- Product quantity
- 389,730 vials
- Termination date
- Oct 11, 2024
- Reason for recall
- CGMP Deviations: potential for trace amounts of product carryover.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 12, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 24, 2023