FDA Recalls Benzoicaine/Menthol Lozenges Due to Potential Labeling Mixup
Aidapak Services is recalling Benzoicaine/Menthol lozenges that may be mislabeled as Lubiprostone or Losartan Potassium.
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: This is an FDA Class II recall involving a labeling mixup, which falls under the 'Minor labeling errors' criterion for Moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling Benzoicaine/Menthol Lozenges, 15 mg/3.6 mg, NDC 63824072016, due to a potential labeling mixup. The recalled lozenges may be mislabeled as Lubiprostone Capsules, 24 mcg, or Losartan Potassium Tablets, 50 mg.
The affected products were repacked and distributed in Arizona, California, Oregon, and Washington. The recall involves specific pedigree codes AD21811_4 and W003273 with expiration dates of May 1, 2014, and June 17, 2014, respectively.
Consumers should check their medication labels and discontinue use if the product matches the recalled description. Patients should consult their healthcare provider for appropriate alternatives if they have been taking the mislabeled product.
The recalled product
- Product
- BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824072016
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 80
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)
- BENZOCAINE/MENTHOL
- Lozenge
- 15 mg/3.6 mg has the following codes Pedigree: AD21811_4
- EXP: 5/1/2014
- Pedigree: W003273
- EXP: 6/17/2014.
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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