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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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
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.
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