Approximately 32,260 vials of Leukine (sargramostim) for Injection are being recalled because the medication failed a quality stability test at the 27-month mark. This prescription drug is used to help patients produce white blood cells after certain medical procedures or exposures. Because the product failed these specific quality standards during long-term storage, it may no longer meet the expected potency or purity requirements, which could impact its effectiveness.
The drug was found to be 'out-of-specification' during stability testing, meaning it did not maintain its required chemical or physical properties over time. Using medication that has lost its potency may result in patients receiving a less effective dose than what was prescribed.
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Sources: FDA iRES · Raw API Response
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