Wockhardt Limited has recalled 49,338 units of Enalapril Maleate (enalapril maleate), a medication used to treat high blood pressure and heart failure. The recall was initiated because the tablets failed to meet required specifications for impurities and degradation, which means the drug may contain substances it should not or may be breaking down prematurely. These products were distributed nationwide in 1000-tablet HDPE containers and are packaged within E-flute cartons.
The failure to meet impurity and degradation specifications could result in the patient receiving an ineffective dose of medication or being exposed to unintended chemical compounds. While this recall is classified as low risk, consistent use of compromised medication could impact the management of blood pressure or heart conditions.
Refund and guidance
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Sources: FDA iRES · Raw API Response
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