Recall: D-0178-2023

Class II - Potentially Harmful

Class IIClassification

2023-01-12Initiated

TerminatedStatus

Nephron Sc IncFirm

Product

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

CGMP Deviations: potential for trace amounts of product carryover.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.