FDA recall D-1458-2016

Product

Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.

Reason for recall

Failed Dissolution Specifications: Out-of-specification results in retained sample.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-08-03

Report date

2016-08-24

Termination date

2017-02-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1458-2016