The Recall Desk
ModerateFDA (Drugs)·D-486-2014·Announced 2014-01-22

Aidapak Recalls Cholecalciferol Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling 2,399 tablets of Cholecalciferol 1000 units because they may be mislabeled as other medications.

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 due to a labeling mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity level.

Plain-English summary

Aidapak Services, LLC is recalling 2,399 tablets of Cholecalciferol, Tablet, 1000 units (NDC 00904582460). The recall is due to a labeling error where the product may be potentially mislabeled as other medications, including Aspirin, Chew Tablet, 81 mg; Multivitamin/Multimineral, Tablet; Cholecalciferol, Tablet, 400 units; or Glycopyrrolate, Tablet, 2 mg.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The affected product has specific pedigree codes and expiration dates, including W003464 (EXP: 6/20/2014), AD33897_37 (EXP: 5/9/2014), W002779 (EXP: 6/6/2014), W003626 (EXP: 6/25/2014), W003827 (EXP: 6/27/2014), and AD33897_34 (EXP: 5/9/2014).

Consumers should check their medication labels and contact their healthcare provider or pharmacist if they have questions about the product. The FDA classifies this recall as Class II, indicating a situation that may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
CHOLECALCIFEROL, Tablet, 1000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582460
Affected units
2,399

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 (14)

  • CHOLECALCIFEROL
  • Tablet
  • 1000 units has the following codes Pedigree: W003464
  • EXP: 6/20/2014
  • Pedigree: AD33897_37
  • EXP: 5/9/2014
  • Pedigree: W002779
  • EXP: 6/6/2014
  • Pedigree: W003626
  • EXP: 6/25/2014
  • Pedigree: W003827
  • EXP: 6/27/2014
  • Pedigree: AD33897_34
  • EXP: 5/9/2014.

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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