Aidapak Recalls Isosorbide Mononitrate Tablets Due to Labeling Mixup
Aidapak Services, LLC is recalling Isosorbide Mononitrate ER tablets because they may be mislabeled as other prescription drugs.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling mixup that could lead to patients taking the wrong medication, which is a risk-of-harm scenario where injury has not yet been reported.
Plain-English summary
Aidapak Services, LLC is recalling Isosorbide Mononitrate ER Tablet, 30 mg, NDC 62175012837, due to a labeling mixup. The affected tablets may be incorrectly labeled as Losartan Potassium, Misoprostol, Hydroxyzine Pamoate, or Glyburide.
The recall involves 700 tablets distributed in Arizona, California, Oregon, and Washington. The source text lists specific pedigree codes and expiration dates for the affected Isosorbide Mononitrate tablets, as well as the NDCs and pedigree codes for the drugs they may be mislabeled as.
Consumers should check their medication labels and contact their pharmacist or healthcare provider if they have the affected product. The FDA classifies this recall as Class II, indicating a situation that may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ISOSORBIDE MONONITRATE ER Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175012837
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 700
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 (11)
- ISOSORBIDE MONONITRATE ER Tablet
- 30 mg has the following codes Pedigree: W003996
- EXP: 7/1/2014
- Pedigree: AD46297_1
- EXP: 5/15/2014
- Pedigree: W003350
- EXP: 6/18/2014
- Pedigree: AD21790_64
- EXP: 5/1/2014
- Pedigree: AD32757_37
- EXP: 5/14/2014.
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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