Leflunomide Tablets Recalled Due to Potential Labeling Mixup
Aidapak Services is recalling Leflunomide 10 mg tablets because they may be mislabeled as Doxycycline or Sevelamer Carbonate.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a labeling mixup for prescription drugs, which poses a risk of administering the wrong medication. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aidapak Services, LLC is recalling Leflunomide Tablet, 10 mg, NDC 23155004303. The recall is due to a labeling mixup where the product may be potentially mislabeled as Doxycycline Hyclate, Capsule, 100 mg, or Sevelamer Carbonate, Tablet, 800 mg.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates for the Leflunomide tablets are W002659 (EXP: 6/5/2014) and W002658 (EXP: 6/4/2014).
Patients and healthcare providers should verify the labeling of their medications to ensure they are receiving the correct drug. If a patient has received a medication that appears to be mislabeled, they should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- LEFLUNOMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155004303
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 60
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 (5)
- LEFLUNOMIDE Tablet
- 10 mg has the following codes Pedigree: W002659
- EXP: 6/5/2014
- Pedigree: W002658
- EXP: 6/4/2014.
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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