Effexor
FDA Recall NDC 0008-0833
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 1 recorded enforcement report(s) associated with Effexor (NDC 0008-0833). A significant event, classified as Class I, was initiated on Mar 06, 2014 by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
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.
Mar 06, 2014
May 28, 2014
49,847 bottles
Recall Profile & Regulatory Data
Event ID
67636
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Pfizer Us Pharmaceutical Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
May 10, 2017
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.
Batch or Lot Expiration Information
Lot# : a) V130142, Exp 10/15; b) V130140, Exp 10/15
Affected Packages Involved in this Recall
0008-0837-20Product
0008-0837-21Product
0008-0837-22Product
0008-0837-02Product
0008-0837-03Product
0008-0833-20Product
0008-0833-21Product
0008-0833-22Product
0008-0833-02Product
0008-0833-03Product
0008-0836-20Product
0008-0836-21Product
0008-0836-22Product
0008-0836-02Product
0008-0836-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
