FDA recall D-0074-2018

Amerisource Health Services · Class III · drug

Product

Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01

Reason for recall

Failed Stability Specifications

Distribution

Nationwide USA and Puerto Rico

Key facts

Status
Terminated
Initiation date
2017-08-29
Report date
2017-11-22
Termination date
2019-08-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0074-2018