Reported Jul 8, 2026 · Ongoing · Updated Sep 16, 2026
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only,…
McKesson
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: McKesson · 6555 State Highway 161 · Irving, TX · 75039-2402
Is this the product you have?
- Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only
- Manufactured byTHYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany
- Distributed byHikma, Berkeley Heights, NJ 07922
- NDC0143-9341-01
- Lot codes and dates
Lot #: CB0046Exp. Date 06/2027
- Amount recalled
- 74 units
Where it was sold
- Nationwide
Why it was recalled
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
This product could cause temporary or reversible health problems — stop using it.
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