D-0178-2023 Class II Terminated
FDA drug recall D-0178-2023 was initiated by Nephron Sc Inc on Jan 12, 2023 and is designated Class II. Reason for recall: CGMP Deviations: potential for trace amounts of product carryover. The recall status is terminated (terminated Oct 11, 2024). Affected quantity: 389,730 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 1, 2023
- Initiation Date
- Jan 12, 2023
- Termination Date
- Oct 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 389,730 vials
Product Description
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.
Reason for Recall
CGMP Deviations: potential for trace amounts of product carryover.
Distribution Pattern
Nationwide in the USA
Code Information
Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0178-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026