FDA recall D-0236-2015

Product

Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India

Reason for recall

Failed Dissolution Specifications; 12 month stability time point

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-09-26

Report date

2014-11-12

Termination date

2015-05-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dubai, N/A, United Arab Emirates

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0236-2015