Recalls / Class II
Class IID-0364-2023
Product
Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01
- 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
- Lot #: 224011, 224021, 224022, 224023 Exp 12/31/2023
Why it was recalled
CGMP Deviations: Potential 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
- 325,080 vials
- Distribution pattern
- United States
Timeline
- Recall initiated
- 2023-02-23
- FDA classified
- 2023-03-01
- Posted by FDA
- 2023-03-08
- Terminated
- 2024-10-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0364-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.