FDA Recalls Fenofibrate Tablets Due to Potential Labeling Error
Aidapak Services, LLC is recalling Fenofibrate 54 mg tablets that may have been mislabeled as Famciclovir 500 mg.
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 and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is voluntarily recalling Fenofibrate, Tablet, 54 mg, NDC 00115551110, due to a potential labeling error. The recalled product may have been mislabeled as Famciclovir, Tablet, 500 mg, NDC 00093811956.
The affected Fenofibrate tablets have the pedigree AD49448_7 and an expiration date of 5/17/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
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 questions about their medication.
The recalled product
- Product
- FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115551110.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 90
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)
- FENOFIBRATE
- Tablet
- 54 mg has the following codes: Pedigree: AD49448_7
- EXP: 5/17/2014.
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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