FDA recall D-1080-2014

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

Reason for recall

Failed Dissolution Specification; 12-Month stability interval.

Distribution

LA, MI, MO, MS & OH

Key facts

Status

Terminated

Initiation date

2013-12-13

Report date

2014-02-12

Termination date

2015-02-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1080-2014