United StatesGemcitabine Injection, 1 g per 26.3 mL (38 mg/mL) single‑dose vial (NDC 0143-9341-01), lot CB0046, exp. 06/2027, manufactured by THYMOORGAN PHARMAZIE and distributed by Hikma, is being recalled by McKesson in the United States. The recall covers 74 units nationwide because the product experienced temperature abuse by being stored at controlled room temperature instead of refrigerated.
What's being recalled
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922. NDC: 0143-9341-01
Recalling firm: McKesson, Irving, TX, United States.
How to identify it
Lot #: CB0046, Exp. Date 06/2027
The hazard
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)