Pfizer Recalls Two Lots of Effexor XR 150 mg Extended-Release Capsules and One Lot of Greenstone's Venlafaxine HCI 150 mg Extended-Release Capsules

Pfizer Inc. is voluntarily recalling one lot of 30-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules.

This action is being taken because of a pharmacist report that one bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn (dofetilide) 0.25 mg in addition to the Effexor XR capsules. Although Pfizer has not received any other such reports, these three lots are being voluntarily recalled as a precaution because they were packaged on the same line.

The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient, where the contraindications and drug-drug interactions with Tikosyn have not been considered by the prescribing physician, could cause serious adverse health consequences that could be fatal.

Although there is a very low probability that other bottles of Effexor XR contain a Tikosyn capsule, Pfizer has initiated this voluntary recall as a precaution.

Effexor XR is a prescription antidepressant indicated for the treatment of major depressive disorder, general anxiety disorder, social anxiety disorder, and panic disorder with or without agoraphobia. Tikosyn is a Class III (cardiac action potential duration prolonging) antiarrhythmic drug. It is used to treat irregular heartbeats (such as atrial fibrillation (AF) and atrial flutter (AFL)) and to maintain normal sinus rhythm (normal heartbeat) in patients with AF or AFL of greater than one week duration who have been converted to normal sinus rhythm.

This recall is to the patient level and involves Pfizer lot numbers V130142 and V130140, which both expire in October 2015, and Greenstone lot number V130014, which expires in August 2015.

These products were distributed nationally to wholesalers, distributors, certain government agencies, patient assistance programmes and retailers, such as pharmacies and hospitals. These direct customers are being notified by UPS next day mail, and Pfizer is arranging for the return of all recalled products.