Wizcure Pharmaa Private Limited is subject to a Class II drug recall initiated by the FDA for their Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops. The recall is due to a lack of assurance of sterility, stemming from the product not being manufactured in conformance with current good manufacturing practices (cGMP). The affected product, a 10 ml bottle, was distributed nationwide across the USA.

This recall signifies a critical failure in manufacturing quality control. Wizcure Pharmaa must immediately cease distribution of the affected product, notify all distributors and customers, and implement a plan for product retrieval and destruction. Failure to comply with recall procedures can result in further enforcement actions by the FDA, including potential fines and suspension of manufacturing operations. The FDA's classification as 'Class II' indicates that the product may cause temporary or medically reversible adverse health consequences, or there is a low probability of serious adverse health consequences.