FDA recall D-0178-2023

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 for recall

CGMP Deviations: potential for trace amounts of product carryover.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-01-12

Report date

2023-02-01

Termination date

2024-10-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Columbia, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0178-2023