FDA recall D-1504-2014

Daiichi Sankyo Pharma Development · Class II · drug

Product

Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30

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-1504-2014