FDA recall D-1502-2014

Daiichi Sankyo Pharma Development · Class II · drug

Product

Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and NDC 65597-103-90

Reason for recall

Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2014-07-12
Report date
2014-08-06
Termination date
2015-03-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Edison, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1502-2014