FDA recall D-1091-2014

Product

Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.

Reason for recall

Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-02-04

Report date

2014-03-12

Termination date

2015-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Elizabeth, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1091-2014