FDAFDA · Food and drugs·Recall number D-0714-2026
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
Published July 8, 2026 · Recall initiated: June 10, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Brand
- GEMCITABINE
- Manufacturer
- McKesson
- Distributor
- Nationwide within the United States
- Lot
- Lot #: CB0046, Exp. Date 06/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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