The Recall Desk
ModerateFDA (Drugs)·D-717-2014·Announced 2014-01-22

Aidapak Recalls Irbesartan Tablets Due to Potential Labeling Mixup

Aidapak Services, LLC is recalling 150 mg Irbesartan tablets because they may be mislabeled as Atropine Sulfate/Diphenoxylate HCl or Cholecalciferol.

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 labeling mixup, which fits the rubric criteria for moderate severity involving minor labeling errors or low-risk contamination without reported injuries.

Plain-English summary

Aidapak Services, LLC is recalling 150 mg Irbesartan tablets (NDC 65862063830) due to a labeling mixup. The recalled product may be potentially mislabeled as Atropine Sulfate/Diphenoxylate HCl tablets (NDC 00378041501) or Cholecalciferol tablets (NDC 00904582360).

The affected Irbesartan tablets are 60-tablet packages distributed in Arizona, California, Oregon, and Washington. The recall involves specific pedigree codes: W003649 with an expiration date of 6/25/2014, and AD73686_7 with an expiration date of 5/31/2014.

Consumers should check their medication for the specific NDC and pedigree codes listed above. If the product matches the description, they should stop using it and contact their pharmacist or healthcare provider for guidance.

The recalled product

Product
IRBESARTAN, Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65862063830
Affected units
60

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 (6)

  • IRBESARTAN
  • Tablet
  • 150 mg has the following codes Pedigree: W003649
  • EXP: 6/25/2014
  • Pedigree: AD73686_7
  • EXP: 5/31/2014.

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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