Recalls / Class III
Class IIID-1067-2013
Product
Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC 28405, USA.
- Affected lot / code info
- Lot #: a) 58975, 58976, 58977, 65165 , Exp 01/14; b) 58973, 58974, 65131, Exp: 01/14
Why it was recalled
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Recalling firm
- Firm
- Osmotica Pharmaceutical Corp
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 895 Sawyer Rd, Marietta, Georgia 30062
Distribution
- Quantity
- 57857 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-09-16
- FDA classified
- 2013-09-27
- Posted by FDA
- 2013-10-09
- Terminated
- 2014-05-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1067-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.