Recalls / Class II
Class IID-0178-2023
Product
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.
- Brand name
- Sterile Water
- Generic name
- Sterile Water
- Active ingredient
- Water
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDC
- 0487-6105
- FDA application
- ANDA211222
- Affected lot / code info
- Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024
Why it was recalled
CGMP Deviations: potential for trace amounts of product carryover.
Recalling firm
- Firm
- Nephron Sc Inc
- Manufacturer
- Nephron Pharmaceuticals Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, N/A, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 389,730 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-01-12
- FDA classified
- 2023-01-24
- Posted by FDA
- 2023-02-01
- Terminated
- 2024-10-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0178-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.