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Recall Observatory FDA recall evidence

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

April 01, 2019

Class III

Product summary

Firm
Lupin Pharmaceuticals Inc.
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

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications