September 2013 FDA Recall Drug by Osmotica Pharmaceutical Corp
D-1067-2013 - Failed Dissolution Specification

This Class III drug recall was voluntarily initiated by Osmotica Pharmaceutical Corp on September 16, 2013 for the product Drug. The FDA reported the reason for recall as failed dissolution specification. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1067-2013

Reason for Recall
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Initiated
09-16-2013
Reported
10-09-2013
Quantity
57857 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66226
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Osmotica Pharmaceutical Corp
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2014
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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