FDA recall D-1505-2014

Daiichi Sankyo Pharma Development · Class II · drug

Product

Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18

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-1505-2014