FDA recall D-1167-2014

McKesson Packaging Services · Class III · drug

Product

Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10

Reason for recall

Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-03-03
Report date: 2014-03-26
Termination date: 2014-08-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Concord, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1167-2014