PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 8, 2023 Initiated: February 23, 2023 #D-0364-2023

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

Reason for Recall

CGMP Deviations: Potential product carryover.

Details

Recalling Firm
Nephron Sc Inc
Units Affected
325,080 vials
Distribution
United States
Location
West Columbia, SC

Frequently Asked Questions

What product was recalled?
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. Recalled by Nephron Sc Inc. Units affected: 325,080 vials.
Why was this product recalled?
CGMP Deviations: Potential product carryover.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 8, 2023. Severity: Moderate. Recall number: D-0364-2023.