May 2014 FDA Recall Drug by Dr. Reddy's Laboratories, Inc.
D-1381-2014 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on May 23, 2014 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1381-2014
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
05-23-2014
06-18-2014
13560 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
05-01-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01
Batch or Lot Expiration Information
Lot# C206578 Exp. 05/2014
Lot# C207415 Exp. 06/2014
