Failed Dissolution Specifications.
Failed Dissolution Specifications.
Consumers and healthcare providers should stop using this product immediately. Contact Amerisource Health Services LLC or your healthcare provider for guidance. Notification method: Letter
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11). Generic: CARBAMAZEPINE; Brand: CARBAMAZEPINE. Reason: Failed Dissolution Specifications.. Classification: Class II. Quantity: 360 cartons. Distribution: Nationwide in the USA.
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
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.