Caplin Steriles Limited is recalling approximately 19, 820 vials of Milrinone Lactate Injection, USP (20mg/20 mL), a medication used to treat heart failure. The recall was issued because the product failed quality tests for impurities and degradation specifications. No injuries or medical incidents have been reported in connection with this recall.
Using medication that contains impurities or has degraded can result in the drug being less effective or potentially causing unexpected side effects. While the risk level is considered low, the product no longer meets the required quality standards for patient use.
Distributed by Armas Pharmaceuticals, Inc. Freehold, NJ
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Sources: FDA iRES · Raw API Response
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