Drug product
Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101.
D-1328-2014
Product summary
- Event
- Event 67636
- Status
- Terminated
- Classification
- Class I
- Quantity
- 49,847 bottles
- Official record key
drug-enforcement:D-1328-2014
Official wording
Reason: Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.
Code information: Lot #: a) V130142, Exp 10/15; b) V130140, Exp 10/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets