Recalls / Class II
Class IID-1409-2014
Product
Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30
- Brand name
- Pristiq
- Generic name
- Desvenlafaxine Succinate
- Active ingredient
- Desvenlafaxine Succinate
- Route
- Oral
- NDCs
- 0008-1210, 0008-1211, 0008-1222
- FDA application
- NDA021992
- Affected lot / code info
- H74477, H74478, Exp. 03/16, H74479, H79766 Exp. 05/16
Why it was recalled
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.
Recalling firm
- Firm
- Pfizer Us Pharmaceutical Group
- Manufacturer
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 220,761 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-04-16
- FDA classified
- 2014-06-24
- Posted by FDA
- 2014-07-02
- Terminated
- 2016-09-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1409-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.