Recall: Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg

Product Detail

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.

Recall Number D-1067-2013

Classification Class III

Code Info Lot #: a) 58975, 58976, 58977, 65165 , Exp 01/14; b) 58973, 58974, 65131, Exp: 01/14

Product Distributed Qty 57857 bottles

Reason For Recall Failed Dissolution Specification; 12 hour time point at 18 months
shelf life

Event Detail

Event Id 66226

Product Type Drugs

Status Ongoing

Recalling Firm

Osmotica Pharmaceutical Corp
City Marietta
State GA
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-09-16

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide