The Recall Desk
SevereFDA (Drugs)·D-714-2014·Announced 2014-01-22

Colesevelam HCL Tablets Recalled for Potential Label Mixup

Aidapak Services is recalling Colesevelam HCL tablets that may be mislabeled as lamoTRIgine due to a labeling error.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as taking the wrong medication) are rated as Severe (4).

Plain-English summary

Aidapak Services, LLC is recalling Colesevelam HCL Tablet, 625 mg, NDC 65597070118, due to a labeling mixup. The recalled product may be potentially mislabeled as lamoTRIgine Tablet, 50 mg (1/2 of 100 mg), NDC 13668004701. The specific pedigree for the recalled Colesevelam HCL tablets is AD46426_19, with an expiration date of 5/15/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should check their inventory for Colesevelam HCL Tablet, 625 mg, with pedigree AD46426_19 and expiration date 5/15/2014. If found, the product should be quarantined and not dispensed or used. Patients should contact their healthcare provider for guidance if they have already taken the medication.

The recalled product

Product
COLESEVELAM HCL Tablet, 625 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65597070118
Affected units
180

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 (3)

  • COLESEVELAM HCL Tablet
  • 625 mg has the following code Pedigree: AD46426_19
  • EXP: 5/15/2014

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 273 recalled by Aidapak Services, LLC 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 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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