Agency classClass IIOur severity:Moderate FDA (Drugs)·D-670-2014·Announced 2014-01-22

Aidapak Recalls Isosorbide Mononitrate Tablets Due to Potential Labeling Errors

Aidapak Services, LLC is recalling Isosorbide Mononitrate 20 mg tablets because they may be mislabeled as other medications. The affected repacked drugs were 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, which typically involves a labeling error that could cause temporary or medically reversible health consequences. No specific injuries or illnesses are reported in the source text.

Plain-English summary

Aidapak Services, LLC is recalling Isosorbide Mononitrate 20 mg tablets (NDC 62175010701) due to a labeling mixup. The recall involves repacked drugs that may be incorrectly labeled as Colchicine 0.6 mg, Losartan Potassium 25 mg, or Sodium Chloride 1 mg tablets. The FDA has classified this as a Class II recall.

The affected products were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates for the potentially mislabeled items include AD52778_22 (EXP: 5/20/2014), AD67989_7 (EXP: 5/28/2014), and W002611 (EXP: 6/4/2014).

Consumers and healthcare providers should check their inventory for these specific NDCs and pedigree codes. If the products are found, they should be returned to the distributor or the FDA. Patients should consult their healthcare provider if they have questions about their medication.

The recalled product

Product: ISOSORBIDE MONONITRATE, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175010701
Manufacturer: Aidapak Services, LLC
Category: Drug — Prescription Medication
Hazard: mis-labeling
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 (8)

ISOSORBIDE MONONITRATE
Tablet
20 mg has the following codes Pedigree: AD52778_31
EXP: 5/20/2014
Pedigree: AD67989_10
EXP: 5/28/2014
Pedigree: W002656
EXP: 6/4/2014.

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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Same hazard · mis labeling