Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin...
FDA Recall #D-1121-2019 — Class III — April 1, 2019
Product Description
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.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
12,504 bottles
Distribution
Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.
Code Information
G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated