AvKARE Inc. is recalling 10 cartons of Phytonadione (Vitamin K1) 5 mg Tablets, an Rx-only medication, because testing showed an impurity level (degradant D) that exceeded approved specifications. This recall affects one specific lot of 30-count unit dose cartons distributed in Los Angeles, California. Consumers who have this medication should not use it and should contact their healthcare provider or pharmacist immediately for guidance.
The product was found to have levels of a chemical impurity called 'degradant D' that were higher than safety standards allow, which could potentially affect the medication's quality and safety.
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Sources: FDA iRES · Raw API Response
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