The Recall Desk
ModerateFDA (Drugs)·D-656-2014·Announced 2014-01-22

Sennosides Tablets Recalled for Potential Labeling Mixup with Saccharomyces Boulardii

Aidapak Services, LLC is recalling Sennosides Tablets due to a potential labeling mixup with Saccharomyces Boulardii capsules. The error involves incorrect product identification on the label.

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 serious injury.

Plain-English summary

Aidapak Services, LLC is recalling Sennosides Tablet, 8.6 mg, Over The Counter, NDC 60258095001. The recall is due to a labeling mixup where the product may be potentially mislabeled as Saccharomyces Boulardii Lyo, Capsule, 250 mg, NDC 00414200007. The affected product has the pedigree AD37063_17 and an expiration date of 5/13/2014.

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

Consumers who have this product should stop using it and contact their pharmacist or the recalling firm for further instructions. The specific hazard is a labeling error that could lead to the administration of the wrong medication.

The recalled product

Product
SENNOSIDES Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258095001
Affected units
300

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 (4)

  • SENNOSIDES
  • Tablet
  • 8.6 mg has the following code Pedigree: AD37063_17
  • EXP: 5/13/2014.

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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