FDA Drugs recall ·
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL)… recall
Read the official FDA notice ↗
Product
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
Why was it recalled?
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: CB0046, Exp. Date 06/2027
Distribution
Nationwide within the United States
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0714-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.