FDA Recall Ongoing 2026 recordClass II
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
- Reason
- Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
- Published
- July 8, 2026
- Distribution
- Nationwide
