FDAClass IIAugust 6, 2014

Welchol Tablets recall

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

Why was Welchol Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot NVWG Exp - 11/30/2016

Product
Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18
Recalling firm
Daiichi Sankyo Pharma Development
Quantity
68 bottles
Distribution
Nationwide
Recall date
August 6, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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