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.
Reported: February 1, 2023 Initiated: January 12, 2023 #D-0178-2023
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.
Details
- Recalling Firm
- Nephron Sc Inc
- Units Affected
- 389,730 vials
- Distribution
- Nationwide in the USA
- Location
- West Columbia, SC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Nephron Sc Inc. Units affected: 389,730 vials.
Why was this product recalled? ▼
CGMP Deviations: potential for trace amounts of product carryover.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 1, 2023. Severity: Moderate. Recall number: D-0178-2023.
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