The Recall Desk
ModerateFDA (Drugs)·D-1505-2014·Announced 2014-08-06

Daiichi Sankyo Recalls Welchol Tablets Due to Temperature Abuse During Shipping

Daiichi Sankyo is recalling 68 bottles of Welchol Tablets (colesevelam HCl) 625 mg because they were not stored at controlled room temperature during shipping.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a storage condition deviation (temperature abuse) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Daiichi Sankyo Pharma Development is recalling 68 bottles of Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, NDC 65597-701-18. The recall is limited to Lot NVWG with an expiration date of 11/30/2016. The affected products were distributed nationwide.

The recall was initiated because the products were not stored at Controlled Room Temperature as per USP guidelines during shipping. This temperature abuse may affect the quality of the medication.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for a replacement or further instructions.

The recalled product

Product
Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18
Manufacturer
Daiichi Sankyo Pharma Development
Category
Drug — Prescription Medication
Hazard
Affected units
68

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot NVWG Exp - 11/30/2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Daiichi Sankyo Pharma Development under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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Same manufacturer · Daiichi Sankyo Pharma Development

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