The Recall Desk
ModerateFDA (Drugs)·D-567-2014·Announced 2014-01-22

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.

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 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
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

Distributed in 4 states:

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.

See all 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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