Class III
Terminated
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.
- Company
- Osmotica Pharmaceutical Corp
- Recall Initiated
- September 16, 2013
- Posted
- October 9, 2013
- Recall Number
- D-1067-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 57857 bottles
- Firm Location
- Marietta, GA, United States
Reason for Recall
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Distribution
Nationwide
Lot / Code Info
Lot #: a) 58975, 58976, 58977, 65165 , Exp 01/14; b) 58973, 58974, 65131, Exp: 01/14
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