FDA recall D-0837-2016

Product

Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.

Reason for recall

Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-03-25

Report date

2016-05-11

Termination date

2016-08-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burbank, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0837-2016