Official recall notice

FDA DrugClass IINotable

FDA Recall: Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusio

Recall date
2026-07-08
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

Product description

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

Affected products

Lot #: CB0046, Exp. Date 06/2027

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