FDA recall D-1361-2014

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.

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

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-03-06

Report date

2014-06-18

Termination date

2017-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Peapack, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1361-2014