Recalls / Class I
Class ID-1361-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- V130014, Exp 08/15
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
Recalling firm
- Firm
- Greenstone Llc
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 100 Route 206 North, N/A, Peapack, New Jersey 07977
Distribution
- Quantity
- 16,018 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-03-06
- FDA classified
- 2014-06-09
- Posted by FDA
- 2014-06-18
- Terminated
- 2017-05-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1361-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.