Recall: D-1121-2019

Class III - Minor Violations

Class IIIClassification

2019-04-01Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

Failed Impurities/Degradation Specifications; 18 month long term stability study.

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.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.