Product: Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06
Reason for recall: Failed Impurities/Degradation Specifications; 18 month long term stability study.
Recall initiated: 20190401
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated