Status
Terminated
Drug Enforcement D-0177-2023
CGMP Deviations: potential for trace amounts of product carryover.
Classification
Class II
Report Date
February 1, 2023
Termination Date
October 11, 2024
Product Information
- Product description
- 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.
- Product quantity
- 378 bags
- Reason for recall
- CGMP Deviations: potential for trace amounts of product carryover.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Nephron Sc Inc
- Address
-
4500 12th Street Ext, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0177-2023
- Event ID
- 91449
- Recall initiation date
- January 12, 2023
- Center classification date
- January 24, 2023
- Code info
- Lot: 271043, Exp. 03/2023
- More code info
- —