PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 18, 2014 Initiated: May 23, 2014 #D-1381-2014

Product Description

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

Reason for Recall

Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.

Details

Units Affected
13560 bottles
Distribution
Nationwide
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 13560 bottles.
Why was this product recalled?
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 18, 2014. Severity: Moderate. Recall number: D-1381-2014.