Recalls / Class I

Class ID-1328-2014

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

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.

Brand name: Effexor
Generic name: Venlafaxine Hydrochloride
Active ingredient: Venlafaxine Hydrochloride
Route: Oral
NDCs: 0008-0836, 0008-0837, 0008-0833
FDA application: NDA020699
Affected lot / code info: Lot #: a) V130142, Exp 10/15; b) V130140, Exp 10/15

Why it was recalled

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.

Recalling firm

Firm: Pfizer Us Pharmaceutical Group
Manufacturer: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Notification channel: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type: Voluntary: Firm initiated
Address: 235 E 42nd St, N/A, New York, New York 10017-5703

Distribution

Quantity: 49,847 bottles
Distribution pattern: Nationwide and Puerto Rico

Timeline

Recall initiated: 2014-03-06
FDA classified: 2014-05-20
Posted by FDA: 2014-05-28
Terminated: 2017-05-10
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1328-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.