FDA Recalls Isosorbide Dinitrate Tablets Due to Labeling Error
Aidapak Services is recalling Isosorbide Dinitrate ER tablets because they may be mislabeled as Cilostazol. Patients should check their medication labels.
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 mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under Moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling Isosorbide Dinitrate ER Tablets, 40 mg, NDC 57664060088. The recall is due to a labeling error where the medication may be mislabeled as Cilostazol, Tablet, 50 mg, NDC 60505252101. The affected product has the pedigree AD23082_4 and an expiration date of 5/3/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text does not specify the number of units affected or report any illnesses or injuries associated with this labeling error.
Patients and consumers should check their medication labels to ensure they are taking the correct drug. If the label indicates Cilostazol but the patient was prescribed Isosorbide Dinitrate, they should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- ISOSORBIDE DINITRATE ER Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664060088
- 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 (4)
- ISOSORBIDE DINITRATE ER
- Tablet
- 40 mg has the following code Pedigree: AD23082_4
- EXP: 5/3/2014.
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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