PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: February 1, 2023 Initiated: January 12, 2023 #D-0177-2023

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.

Reason for Recall

CGMP Deviations: potential for trace amounts of product carryover.

Details

Recalling Firm
Nephron Sc Inc
Units Affected
378 bags
Distribution
Nationwide in the USA
Location
West Columbia, SC

Frequently Asked Questions

What product was recalled?
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.. Recalled by Nephron Sc Inc. Units affected: 378 bags.
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-0177-2023.