McKesson: 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: THYMOO
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- McKesson
- 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
- Reason / hazard
- Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the United States
- Recall initiated
- 2026-06-10
- Code info
- Lot #: CB0046, Exp. Date 06/2027
- Product quantity
- 74 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Irving
- State
- TX
- Country
- United States
- Event id
- 99262
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