FDA recall D-1153-2014

Product

Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50

Reason for recall

Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-02-10

Report date

2014-03-19

Termination date

2014-08-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Elizabeth, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1153-2014