December 2013 FDA Recall Drug by Dr. Reddy's Laboratories, Inc.
D-1080-2014 - Failed Dissolution Specification; 12-Month stability interval.
This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on December 13, 2013 for the product Drug. The FDA reported the reason for recall as failed dissolution specification; 12-month stability interval.. The product was distributed in LA, MI, MO, MS & OH and the recall is currently terminated.
Recall Number: D-1080-2014
Failed Dissolution Specification; 12-Month stability interval.
12-13-2013
02-12-2014
8,592 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.
LA, MI, MO, MS & OH
02-12-2015
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, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's Laboratories Limited Bachepalli -500 090 INDIA NDC 55111-467-01
Batch or Lot Expiration Information
Lot# C207420 and C207416
