D-1361-2014 Class I Terminated
FDA drug recall D-1361-2014 was initiated by Greenstone Llc on March 6, 2014 and is designated Class I. 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 … The recall status is terminated (terminated May 10, 2017). Affected quantity: 16,018 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 18, 2014
- Initiation Date
- March 6, 2014
- Termination Date
- May 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,018 bottles
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.
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
Distribution Pattern
Nationwide and Puerto Rico
Code Information
V130014, Exp 08/15