Home / Recalls / Nephron Sc Inc / D-0178-2023

D-0178-2023 Class II Terminated

Recalled by Nephron Sc Inc — West Columbia, SC

Recall Details

Product Type
Drugs
Report Date
February 1, 2023
Initiation Date
January 12, 2023
Termination Date
October 11, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
389,730 vials

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024

Other recalls by Nephron Sc Inc

  • D-0364-2023 Class II — Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 45 (February 23, 2023)
  • D-0175-2023 Class II — Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, US (January 13, 2023)
  • D-0176-2023 Class II — S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Steril (January 13, 2023)
  • D-0177-2023 Class II — 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, (January 12, 2023)
  • D-1354-2022 Class II — Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL si (August 10, 2022)