Drug 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
D-1121-2019
Product summary
- Event
- Event 82528
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12,504 bottles
- Official record key
drug-enforcement:D-1121-2019
Official wording
Reason: Failed Impurities/Degradation Specifications; 18 month long term stability study.
Code information: G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019
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.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications