Home / Recalls / Nephron Sc Inc / D-1354-2022

D-1354-2022 Class II Terminated

Recalled by Nephron Sc Inc — West Columbia, SC

Recall Details

Product Type
Drugs
Report Date
August 24, 2022
Initiation Date
August 10, 2022
Termination Date
September 24, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5040 vials

Product Description

Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01

Reason for Recall

cGMP Deviations: deviations leading to potential cross-contamination.

Distribution Pattern

USA Nationwide

Code Information

Lot#: 023011 Exp 8/31/2022

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-0178-2023 Class II — Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vi (January 12, 2023)
  • D-0177-2023 Class II — 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, (January 12, 2023)