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www.fdanews.com/articles/163097-pfizer-recalls-antidepressant-after-packaging-mishap

Pfizer Recalls Antidepressant After Packaging Mishap

March 14, 2014

Pfizer is recalling three lots of drug products after a packaging mix-up led to a capsule of the wrong drug product in a bottle of an antidepressant.

Pfizer said it received a report from a pharmacist that one capsule of the antiarrhythmic drug Tikosyn (dofetilide) was found in a bottle of antidepressant Effexor XR (venlafaxine HCl) extended-release capsules.

The drugmaker said it hasn’t received any other reports of mix-ups. It is recalling two lots of 150 mg Effexor XR and a lot of generic 150 mg venlafaxine HCl sold by Pfizer subsidiary Greenstone LLC because they were packaged on the same line, Pfizer said.

An Effexor XR patient inadvertently taking Tikosyn could cause serious adverse health consequences, including death, if the contraindications and drug-drug interactions with Tikosyn were not considered by the prescribing physician, the drugmaker said.

Effexor raked in $45 million in U.S. sales during the fourth quarter of 2013, a six-fold increase over $7 million generated during the same period in 2012.

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