FDA recall D-0990-2018

Aidarex Pharmaceuticals LLC · Class III · drug

Product

Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90

Reason for recall

Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.

Distribution

Distributed Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2018-06-27
Report date
2018-08-01
Termination date
2019-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Corona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0990-2018