Recalls / Class II
Class IID-0177-2023
Product
0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 3.
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDC
- 0487-4301
- FDA application
- ANDA211968
- Affected lot / code info
- Lot: 271043, Exp. 03/2023
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
- 378 bags
- 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-0177-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.