FDA recall D-018-2014

Actavis Elizabeth LLC · Class II · drug

Product

Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11

Reason for recall

Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2013-10-09
Report date
2013-12-04
Termination date
2014-11-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Elizabeth, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-018-2014