FDA-Drug2019-04-17Class III
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
Lupin Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Sold states
Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.
Affected count
12,504 bottles
Manufactured in
111 S Calvert St Fl 21ST, N/A, Baltimore, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1121-2019Don't want to check this manually?
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