Teva Pharmaceuticals USA Inc. is recalling 3,109 cartons of Alprostadil Injection USP (500 mcg/mL), a medication used for certain heart and blood flow conditions. The recall was initiated after routine stability testing found that the product did not meet standards for impurities and degradation. No injuries or incidents have been reported to date, but the medication was distributed nationwide to hospitals, pharmacies, and healthcare providers.
The drug may degrade over time, leading to higher-than-allowed levels of impurities. For an injectable medication, these chemical changes could potentially reduce the drug's effectiveness or cause adverse reactions in patients.
Quantity affected: 3,109 cartons. Recall number: D-0988-2022.
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Sources: FDA iRES · Raw API Response
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