September 2012 FDA Recall Drug by Dr. Reddy's Laboratories, Inc.
D-059-2013 - Failed USP Dissolution Test Requirements

This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on September 27, 2012 for the product Drug. The FDA reported the reason for recall as failed usp dissolution test requirements. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-059-2013

Reason for Recall
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Initiated
09-27-2012
Reported
11-28-2012
Quantity
1512 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63524
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
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. No foreign consignees.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-10-2013
Product Description About Product Description
Full technical description of the product.
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05

Batch or Lot Expiration Information

Lot# Lot C203090 Exp.03/14