FDA recall D-1508-2014

Product

Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90

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-1508-2014