Aidapak Recalls Fenofibrate Tablets Due to Potential Labeling Errors
Aidapak Services, LLC is recalling specific lots of Fenofibrate 54 mg tablets because they may have been mislabeled as other prescription drugs.
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 and involves a labeling error (label mixup) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling 270-count bottles of Fenofibrate, Tablet, 54 mg (NDC 00378710077) due to a labeling error. The recalled product may have been mislabeled as Lubiprostone, Capsule, 24 MCG; aMILoride HCl, Tablet, 5 mg; or Propranolol HCL, Tablet, 10 mg.
The affected lots have pedigree codes AD21790_52 (expiration 5/1/2014), AD60272_64 (expiration 5/22/2014), and W002733 (expiration 6/6/2014). These repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for these specific pedigree codes and expiration dates. If the product matches the recalled description, it should be returned to the pharmacy or supplier for replacement or refund.
The recalled product
- Product
- FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378710077.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 270
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 (8)
- FENOFIBRATE
- Tablet
- 54 mg has the following codes: Pedigree: AD21790_52
- EXP: 5/1/2014
- Pedigree: AD60272_64
- EXP: 5/22/2014
- Pedigree: W002733
- EXP: 6/6/2014.
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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