Aidapak Recalls Isosorbide Dinitrate Tablets Due to Labeling Errors
Aidapak Services, LLC is recalling Isosorbide Dinitrate 5 mg tablets that may have been mislabeled as Cilostazol or Perphenazine.
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 mixup without reported illnesses, fitting the criteria for moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling Isosorbide Dinitrate, Tablet, 5 mg (NDC 00781163501) due to a labeling error. The recalled tablets may have been mislabeled as Cilostazol, Tablet, 100 mg (NDC 00054004421) or Perphenazine, Tablet, 8 mg (NDC 00630506221). The affected products are prescription-only medications distributed in Arizona, California, Oregon, and Washington.
The recall involves specific lots with the following pedigree and expiration codes: Pedigree W003474 with an expiration date of 6/20/2014, and Pedigree AD56882_1 with an expiration date of 5/21/2014. The source text does not report any illnesses or injuries associated with this recall.
Patients and healthcare providers should check their medication labels and contact their pharmacist or prescriber if they have received these specific products. Do not take the medication if the label does not match the prescription.
The recalled product
- Product
- ISOSORBIDE DINITRATE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781163501.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 200
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
- 5 mg has the following codes: Pedigree: W003474
- EXP: 6/20/2014
- Pedigree: AD56882_1
- EXP: 5/21/2014.
Distribution
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.
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