The announcement has been issued following cross-contamination of the tablets from a small amount of enalapril maleate, another drug substance, used to manufacture another product at the same facility. The 100mg tablets in 100 count bottles are being recalled at the consumer level.
Enalapril maleate is a substance indicated for hypertension and congestive heart failure. According to the FDA, exposure from the substance could potentially impact patients particularly if they are small children or pregnant women; enalapril maleate is associated with risk of birth defects in a developing foetus.
So far, Taro Pharmaceuticals has not received any product complaints or reports of adverse events.