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.
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.
Lot numbers, UPCs & expiration codes
Lot #: a) V130142, Exp 10/15; b) V130140, Exp 10/15
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1328-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 6, 2014
- FDA report date
- May 28, 2014
- Quantity
- 49,847 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Us Pharmaceutical Group
Original FDA data
Every field from FDA enforcement report D-1328-2014, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 67636
- Address
- 235 E 42nd St
- Code information
- Lot #: a) V130142, Exp 10/15; b) V130140, Exp 10/15
- Postal code
- 10017-5703
- Report date
- May 28, 2014
- Product type
- Drugs
- Recall number
- D-1328-2014
- Classification
- Class I
- Recalling firm
- Pfizer Us Pharmaceutical Group
- Product quantity
- 49,847 bottles
- Termination date
- May 10, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 6, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 20, 2014