FDA recall D-0913-2018

Wockhardt Limited · Class III · drug

Product

Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2018-06-19
Report date: 2018-07-18
Termination date: 2020-04-13
Voluntary/Mandated: —
Location: Karodi, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0913-2018