FDA recall D-1409-2014

Pfizer Us Pharmaceutical Group · Class II · drug

Product

Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30

Reason for recall

Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2014-04-16
Report date
2014-07-02
Termination date
2016-09-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1409-2014