Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: Letter
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.. Generic: ENTECAVIR; Brand: ENTECAVIR. Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity. Classification: Class II. Quantity: 600 30-count bottles. Distribution: Distributed Nationwide in the USA
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Glenmark Pharmaceuticals Inc. recalled 13,824 tubes of Azelaic Acid Gel on September 17, 2025. The recall stems from market complaints regarding a gritty texture. Consumers should stop using the product immediately and contact their healthcare provider.
Failed Dissolution Specifications.