Status
Terminated
Drug Enforcement D-0364-2023
CGMP Deviations: Potential product carryover.
Classification
Class II
Report Date
March 8, 2023
Termination Date
October 11, 2024
Product Information
- Product description
- 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
- Product quantity
- 325,080 vials
- Reason for recall
- CGMP Deviations: Potential product carryover.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- United States
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-0364-2023
- Event ID
- 91767
- Recall initiation date
- February 23, 2023
- Center classification date
- March 1, 2023
- Code info
- Lot #: 224011, 224021, 224022, 224023 Exp 12/31/2023
- More code info
- —