Dissolution Problems Prompt Recall by Dr. Reddy's - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Dissolution Problems Prompt Recall by Dr. Reddy's


FDA has reported that Dr. Reddy’s Laboratories has initiated a voluntary recall for Metoprolol Succinate Extended Release Tablets, USP 25 mg, 100-count bottle for failed dissolution specifications.

The recall, initiated on May 23, 2014, involves 13,560 bottles, was for failure of a dissolution test observed at an 18-month time point and involved two lots.

FDA classified the recall as Class II, 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.

Source: FDA

 

 

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
24%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
10%
All of the above.
44%
No government involvement in patient treatment or drug development.
10%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?

Click here