The Recall Desk
ModerateFDA (Drugs)·D-1000-2014·Announced 2014-01-29

Aidapak Recalls Isosorbide Dinitrate Tablets Due to Labeling Errors

Aidapak Services, LLC is recalling Isosorbide Dinitrate 10 mg tablets because they may have been mislabeled as Sodium Chloride or Calcitriol.

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. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are classified as Moderate (Score 2).

Plain-English summary

Aidapak Services, LLC is recalling Isosorbide Dinitrate, Tablet, 10 mg (NDC 00781155601) due to a labeling error. The recalled tablets may have been mislabeled as Sodium Chloride, Tablet, 1 mg (NDC 00223176001) or Calcitriol, Capsule, 0.5 mcg (NDC 63304024001). The recall involves 384 tablets per unit.

The affected lots have pedigree codes AD25264_1 (expiration date 5/3/2014) and AD32757_34 (expiration date 5/14/2014). The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This is an FDA Class II recall, indicating a situation that might temporarily cause adverse health consequences or where the probability of serious adverse health consequences is remote.

Patients and healthcare providers should check their medication labels and contact their pharmacist or prescriber if they have received Isosorbide Dinitrate 10 mg tablets that are labeled as Sodium Chloride or Calcitriol. Do not take the medication if the label does not match the prescribed drug.

The recalled product

Product
ISOSORBIDE DINITRATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781155601.
Affected units
384

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)

  • ISOSORBIDE DINITRATE
  • Tablet
  • 10 mg has the following codes: Pedigree: AD25264_1
  • EXP: 5/3/2014
  • Pedigree: AD32757_34
  • EXP: 5/14/2014.

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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