Drug product
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.
D-1361-2014
Product summary
- Firm
- Greenstone Llc
- Event
- Event 67637
- Status
- Terminated
- Classification
- Class I
- Quantity
- 16,018 bottles
- Official record key
drug-enforcement:D-1361-2014
Official wording
Reason: 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
Code information: V130014, Exp 08/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets