FDA 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.

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.

Key facts

Status

Terminated

Initiation date

2019-04-01

Report date

2019-04-17

Termination date

2020-07-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1121-2019