Finasteride Tablets Recalled for Potential Mislabeling as Other Medications
Aidapak Services is recalling Finasteride 5 mg tablets that may be mislabeled as Digoxin or Phytonadione. The error poses a risk of incorrect medication administration.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant harm (such as administering the wrong medication) are rated as Severe (4).
Plain-English summary
Aidapak Services, LLC is recalling Finasteride 5 mg tablets (NDC 16714052201) due to a labeling error. The source text indicates that these tablets may be potentially mislabeled as Digoxin 0.125 mg tablets or Phytonadione 5 mg tablets. This mixup creates a risk that patients may receive or administer the wrong medication.
The recalled products were repacked and distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates are associated with the potentially mislabeled items, including Pedigree AD62829_8 (EXP 5/23/2014) and Pedigree W003061 (EXP 5/31/2014).
Consumers and healthcare providers should check their medication labels to ensure they match the prescription. If a patient has received a medication that appears to be mislabeled, they should contact their pharmacist or physician for guidance. 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.
The recalled product
- Product
- FINASTERIDE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714052201
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 120
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)
- FINASTERIDE Tablet
- 5 mg has the following codes Pedigree: AD62846_1
- EXP: 2/28/2014
- Pedigree: W003031
- EXP: 2/28/2014.
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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