Product: Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
Reason for recall: Failed Dissolution Specifications
Recall initiated: 20250919
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated