FDA recall D-1381-2014

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-05-23

Report date

2014-06-18

Termination date

2015-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1381-2014