Lupin Pharmaceuticals Inc. recalls Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.,
Recalled April 17, 2019 · FDA recall D-1121-2019 · Lupin Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications; 18 month long term stability study. · FDA Class III
Units
12,504 bottles
Sold at
Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.
Description
Failed Impurities/Degradation Specifications; 18 month long term stability study.
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
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →