Cardinal Health Recalls Gemcitabine Injection Due to Temperature Excursions
Cardinal Health is recalling Gemcitabine Injection 200mg/5.26ml vials due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
What this means for you
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: The recall is classified as FDA Class II, which is typically associated with a temporary or medically reversible adverse health consequence. The hazard is a CGMP deviation (temperature excursion) without reported illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Cardinal Health Inc. is recalling Gemcitabine Injection 200mg/5.26ml single-dose vials (NDC 72485-221-02). The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.
The affected product was distributed in Florida, Georgia, and South Carolina. The specific code for the recalled units is 7T10050A.
Healthcare providers and patients should stop using the recalled product and contact their pharmacist or healthcare provider for instructions on how to return or dispose of the medication. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Antineoplastic
- Affected units
- 3
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 (1)
- 7T10050A
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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