FDA recall D-1683-2012

Apace KY LLC · Class III · drug

Product

Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30

Reason for recall

Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2012-09-04
Report date
2012-09-26
Termination date
2013-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fountain Run, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1683-2012