Gemcitabine Injection Recalled Due to Temperature Storage Abuse
McKesson is recalling Gemcitabine Injection (1 g per 26.3 mL) due to temperature abuse—the product was stored at controlled room temperature instead of under refrigeration. The affected lot was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving improper storage conditions that may affect product stability and efficacy. No reported illnesses or injuries are mentioned in the source, and the hazard is storage-related rather than contamination or structural defect. Class II recalls with no reported adverse events typically fall in the Moderate range per the rubric.
Plain-English summary
McKesson is recalling Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), Single-Dose Vials for intravenous infusion. The recall was initiated because the product was stored in a controlled room temperature environment instead of the required refrigerated environment, which may have compromised product integrity and efficacy.
The affected product is Lot #CB0046 with an expiration date of 06/2027 (NDC 0143-9341-01). Approximately 74 units were distributed nationwide within the United States.
Patients and healthcare providers who have received or dispensed this product should discontinue use and contact their supplier or McKesson for instructions on return or replacement. Healthcare facilities should review their records to identify any units from the affected lot that may have been used or dispensed.
The recalled product
- Product
- GEMCITABINE (GEMCITABINE)
- Brand
- GEMCITABINE
- Manufacturer
- McKesson
- Category
- Drug — Injectable / Oncology
- Affected units
- 74
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: CB0046
- Exp. Date 06/2027
Distribution
Distributed nationwide across the United States.
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