Drug recall D-1121-2019
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.
Lots and codes
G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- 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.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 1, 2019
- Terminated
- July 1, 2020
Related products
- Telmisartan and Amlodipine – drug information
- NDC 68180-196 Telmisartan and Amlodipine · Telmisartan 40 mg/1; Amlodipine Besylate 5 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-197 Telmisartan and Amlodipine · Telmisartan 40 mg/1; Amlodipine Besylate 10 mg/1 · Lupin Pharmaceuticals, Inc.