The Recall Desk
ModerateFDA (Drugs)·D-669-2014·Announced 2014-01-22

FDA Recalls Isosorbide Mononitrate Tablets Due to Labeling Error

Aidapak Services is recalling Isosorbide Mononitrate 10 mg tablets that may be mislabeled as Ascorbic Acid 250 mg. The error affects specific lots 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 and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

The U.S. Food and Drug Administration has issued a recall for Isosorbide Mononitrate Tablet, 10 mg, distributed by Aidapak Services, LLC. The recall is due to a labeling error where the medication may be mislabeled as Ascorbic Acid, Tablet, 250 mg.

The affected product is identified by NDC 62175010601, Pedigree AD28352_1, and expiration date 5/7/2014. The mislabeled product is identified by NDC 00904052260, Pedigree AD28322_10, and expiration date 5/6/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers should check their medication for these specific codes and expiration dates. If the product matches the description, they should stop using it and contact their pharmacist or healthcare provider for guidance.

The recalled product

Product
ISOSORBIDE MONONITRATE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175010601
Affected units
100

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 (3)

  • ISOSORBIDE MONONITRATE Tablet
  • 10 mg has the following code Pedigree: AD28352_1
  • EXP: 5/7/2014.

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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