FDA Recalls Fexofenadine Tablets Due to Potential Labeling Mixup
Aidapak Services is recalling Fexofenadine HCl tablets that may be mislabeled as Pyridoxine, Niacin, or Cranberry Extract.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential mislabeling that could lead to incorrect medication administration.
Plain-English summary
Aidapak Services, LLC is voluntarily recalling Fexofenadine HCl Tablets, 60 mg, NDC 45802042578, due to a potential labeling mixup. The recalled product may be mislabeled as Pyridoxine HCl, Tablet, 50 mg; Niacin TR, Capsule, 500 mg; or Cranberry Extract/Vitamin C, Capsule, 450 mg/125 mg.
The recall involves repacked drugs distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates for the affected lots are listed in the agency's official notice. The FDA has classified this recall as Class II, indicating a situation that may cause temporary or medically reversible adverse health consequences.
Consumers who have purchased these specific Fexofenadine HCl tablets should stop using them and contact their pharmacist or the recalling firm for instructions on how to return the product. Patients should consult their healthcare provider before switching to alternative medications.
The recalled product
- Product
- FEXOFENADINE HCl Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802042578
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 300
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 (7)
- FEXOFENADINE HCL Tablet
- 60 mg has the following codes Pedigree: W003020
- EXP: 6/12/2014
- Pedigree: AD60240_30
- EXP: 5/22/2014
- Pedigree: AD46257_50
- EXP: 5/15/2014.
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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