FDA Recall D-1361-2014
Greenstone Llc · Peapack, NJ
Class I — life-threatening Terminated 1161 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-1361-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide and Puerto Rico
- Recall initiated
- 2014-03-06
- Classified by FDA Center
- 2014-06-09
- FDA published
- 2014-06-18
- Terminated
- 2017-05-10
- Recalling firm
- Greenstone Llc
- Firm location
- Peapack, NJ