The Recall Desk
ModerateFDA (Drugs)·D-934-2014·Announced 2014-01-29

Aidapak Recalls Docusate Calcium Capsules Due to Labeling Errors

Aidapak Services, LLC is recalling 1,109 docusate calcium capsules because they may have been mislabeled as other medications. The affected products were distributed in four western states.

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 error (mislabeling) which is a minor labeling issue that may cause temporary adverse health consequences, fitting the Moderate severity criteria for low-risk contamination or labeling errors without reported serious injury.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling 1,109 capsules of docusate calcium, 240 mg, over-the-counter medication. The recall is due to a labeling error where the product may have been mislabeled as diphenhydramine HCl, 25 mg tablets, or dutasteride, 0.5 mg capsules. The specific NDC for the recalled docusate calcium is 00536375501.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text identifies four specific pedigree codes and expiration dates associated with the recall: AD33897_16 (EXP 5/9/2014), AD49582_16 (EXP 5/16/2014), W002776 (EXP 6/6/2014), and W003821 (EXP 6/27/2014). The source text lists potential mislabeling scenarios involving NDCs 00904555159 and 00173071215, but does not specify which exact units were mislabeled.

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

The recalled product

Product
DOCUSATE CALCIUM, Capsule, 240 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375501.
Affected units
1,109

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 (10)

  • DOCUSATE CALCIUM
  • Capsule
  • 240 mg has the following codes: Pedigree: AD33897_16
  • EXP: 5/9/2014
  • Pedigree: AD49582_16
  • EXP: 5/16/2014
  • Pedigree: W002776
  • EXP: 6/6/2014
  • Pedigree: W003821
  • EXP: 6/27/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 265 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 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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