FDA-Drug2014-08-06Class II

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

Daiichi Sankyo Pharma Development
Hazard

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

Sold states
Nationwide
Affected count
68 bottles
Manufactured in
399 Thornall St, Edison, NJ, United States
Products
Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1505-2014

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