D-1121-2019 Class III Terminated
FDA drug recall D-1121-2019 was initiated by Lupin Pharmaceuticals Inc. on April 1, 2019 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications; 18 month long term stability study. The recall status is terminated (terminated July 1, 2020). Affected quantity: 12,504 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 17, 2019
- Initiation Date
- April 1, 2019
- Termination Date
- July 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,504 bottles
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.
Distribution Pattern
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