Recall Enforment Report D-1328-2014

Drug Recall Enforcement Report Class I voluntary initiated by Pfizer Us Pharmaceutical Group, originally initiated on 03-06-2014 for the 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. The product was recalled due to 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.. The product was distributed nationwide and the recall is currently terminated.

Field Name	Field Value
Event ID	67636 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1328-2014 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide and Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	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.
Reason For Recall	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. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	49,847 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	05-28-2014
Recall Initiation Date	03-06-2014 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	05-10-2017 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Pfizer Us Pharmaceutical Group
Code Info	Lot #: a) V130142, Exp 10/15; b) V130140, Exp 10/15 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0008-0837-20; 0008-0837-21; 0008-0837-22; 0008-0837-02; 0008-0837-03; 0008-0833-20; 0008-0833-21; 0008-0833-22; 0008-0833-02; 0008-0833-03; 0008-0836-20; 0008-0836-21; 0008-0836-22; 0008-0836-02; 0008-0836-03
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products