Aidapak Recalls Isometheptene Mucate Capsules Due to Labeling Errors
Aidapak Services, LLC is recalling Isometheptene Mucate capsules because they may be mislabeled as other medications. The error could lead to patients receiving the wrong drug.
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 due to a labeling error (mislabeling) which is a moderate risk. The rubric assigns a score of 2 for minor labeling errors or low-risk contamination, as no injuries or illnesses are reported in the source text.
Plain-English summary
Aidapak Services, LLC is recalling Isometheptene Mucate/Dichlorphenazone/APAP Capsules (65 mg/100 mg/325 mg) because the product may be mislabeled. The recall is due to a labeling mixup where the capsules could be incorrectly identified as Albuterol Sulfate ER Tablets (4 mg) or Losartan Potassium Tablets (25 mg).
The affected product is distributed in Arizona, California, Oregon, and Washington. The recall involves specific lots with pedigree numbers W003596 (expiration 5/31/2014) and AD22858_1 (expiration 3/31/2014). The mislabeling risk involves potential confusion with Albuterol Sulfate ER (pedigree W003578, expiration 6/24/2014) and Losartan Potassium (pedigree AD22616_7, expiration 5/2/2014).
Patients and healthcare providers should check their medication labels and contact their pharmacist or physician if they have questions about the product. The FDA has classified this as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 44183044001
- 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)
- ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP
- Capsule
- 65 mg/100 mg/325 mg has the following codes Pedigree: W003596
- EXP: 5/31/2014
- Pedigree: AD22858_1
- EXP: 3/31/2014.
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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