Lupin Pharmaceuticals Inc. recalls Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.…

Recall date

April 1, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1121-2019

FDA classification

Class III

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.

Why it was recalled

Failed Impurities/Degradation Specifications; 18 month long term stability study.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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