Status
Terminated
Drug Enforcement D-1067-2013
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Classification
Class III
Report Date
October 9, 2013
Termination Date
May 9, 2014
Product Information
- Product description
- 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.
- Product quantity
- 57857 bottles
- Reason for recall
- Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Osmotica Pharmaceutical Corp
- Address
-
895 Sawyer Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1067-2013
- Event ID
- 66226
- Recall initiation date
- September 16, 2013
- Center classification date
- September 27, 2013
- Code info
- Lot #: a) 58975, 58976, 58977, 65165 , Exp 01/14; b) 58973, 58974, 65131, Exp: 01/14
- More code info
- —