Montelukast Sodium Chew Tablets Recalled for Potential Labeling Error
Aidapak Services is recalling Montelukast Sodium chew tablets that may be mislabeled as Dicyclomine HCL. The error could lead to patients taking the wrong medication.
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 temporary or medically reversible adverse health consequence. The hazard is a labeling mixup, which is a significant error but does not involve a known pathogen or structural defect leading to immediate severe injury in this context.
Plain-English summary
Aidapak Services, LLC is recalling Montelukast Sodium, Chew Tablet, 4 mg, NDC 00006071131. The recall is due to a labeling error where the product may be mislabeled as Dicyclomine HCL, Tablet, 20 mg, NDC 00591079501. The affected product has the pedigree AD76639_11 and an expiration date of 5/31/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This labeling mixup poses a risk that patients may inadvertently take Dicyclomine HCL instead of Montelukast Sodium, or vice versa, depending on the specific packaging error.
Consumers and healthcare providers should check their inventory for the specific NDC and pedigree listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have taken the wrong medication.
The recalled product
- Product
- MONTELUKAST SODIUM, CHEW Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006071131.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 30
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)
- MONTELUKAST SODIUM
- CHEW Tablet
- 4 mg has the following codes: Pedigree: AD76639_11
- EXP: 5/31/2014.
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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