Aidapak Recalls Nabumetone Tablets Due to Potential Labeling Mixup
Aidapak Services, LLC is recalling Nabumetone 500 mg tablets that may have been mislabeled as guaiFENesin ER 600 mg. The FDA classifies this as a Class II recall.
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 mixup. According to the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity level.
Plain-English summary
Aidapak Services, LLC is recalling Nabumetone, Tablet, 500 mg, Rx only, NDC 00185014501. The recall is due to a labeling mixup where the product may have been mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000834. The affected Nabumetone tablets have the pedigree AD46426_4 and an expiration date of 5/15/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for Nabumetone 500 mg tablets with the specified pedigree and expiration date. If found, these products should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- NABUMETONE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185014501.
- 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)
- NABUMETONE
- Tablet
- 500 mg has the following codes: Pedigree: AD46426_4
- EXP: 5/15/2014.
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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