Drug product
Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30
D-1409-2014
Product summary
- Event
- Event 68001
- Status
- Terminated
- Classification
- Class II
- Quantity
- 220,761 bottles
- Official record key
drug-enforcement:D-1409-2014
Official wording
Reason: 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.
Code information: H74477, H74478, Exp. 03/16, H74479, H79766 Exp. 05/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets