Why it was recalled
Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot
Product description
Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9.
Lot numbers, UPCs & expiration codes
V130014, Exp 08/15
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-1361-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 6, 2014
- FDA report date
- Jun 18, 2014
- Quantity
- 16,018 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Greenstone Llc
Original FDA data
Every field from FDA enforcement report D-1361-2014, exactly as published.
Show all FDA fields
- City
- Peapack
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67637
- Address
- 100 Route 206 North
- Code information
- V130014, Exp 08/15
- Postal code
- 07977
- Report date
- Jun 18, 2014
- Product type
- Drugs
- Recall number
- D-1361-2014
- Classification
- Class I
- Recalling firm
- Greenstone Llc
- Product quantity
- 16,018 bottles
- Termination date
- May 10, 2017
- Reason for recall
- Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9.
- 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
- Jun 9, 2014