FDA recall D-1122-2019

AVKARE Inc. · Class III · drug

Product

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30

Reason for recall

Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)

Distribution

AZ, CO

Key facts

Status: Terminated
Initiation date: 2019-04-03
Report date: 2019-04-17
Termination date: 2020-05-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1122-2019