The Recall Desk
ModerateFDA (Drugs)·D-843-2014·Announced 2014-01-29

Aidapak Recalls Mislabeled Amlodipine Tablets Due to Label Mixup

Aidapak Services, LLC is recalling 5 mg amlodipine besylate tablets that may have been mislabeled as cyanocobalamin. The error involves a label mixup affecting specific lots.

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 (label mixup). While mislabeling can be serious, the rubric categorizes minor labeling errors and low-risk contamination as Moderate (Score 2), especially when no specific injuries or illnesses are reported in the source text.

Plain-English summary

Aidapak Services, LLC is recalling 90-count bottles of amlodipine besylate tablets, 5 mg, NDC 00093716798. The recall is due to a labeling error where the product may have been mislabeled as cyanocobalamin tablets, 1000 mcg, NDC 00904421713. The affected amlodipine tablets have pedigree W002840 and an expiration date of 6/7/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This is a Class II recall, indicating that 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 amlodipine besylate tablets with the specific pedigree and expiration date listed above. If found, these products should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions about their medication.

The recalled product

Product
amLODIPine BESYLATE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093716798.
Affected units
90

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)

  • amLODIPine BESYLATE
  • Tablet
  • 5 mg has the following codes: Pedigree: W002840
  • EXP: 6/7/2014.

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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