Aidapak Recalls Amlodipine Tablets Due to Potential Labeling Error
Aidapak Services, LLC is recalling 10 mg amlodipine besylate tablets that may be mislabeled as 5 mg finasteride tablets.
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 mixup between two different prescription medications. This fits the rubric for moderate severity involving labeling errors without reported injuries.
Plain-English summary
Aidapak Services, LLC is recalling 90-count bottles of amlodipine besylate tablets, 10 mg, NDC 68382012316. The recall is due to a labeling mixup where the product may be mislabeled as finasteride tablets, 5 mg, NDC 16714052201.
The affected amlodipine tablets have the pedigree AD62846_4 and an expiration date of 5/24/2014. The potentially mislabeled finasteride tablets have the pedigree AD62846_1 and an expiration date of 2/28/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance on whether to continue taking the medication or to obtain a replacement.
The recalled product
- Product
- amLODIPine BESYLATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68382012316
- 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)
- amLODIPine BESYLATE
- Tablet
- 10 mg has the following code Pedigree: AD62846_4
- EXP: 5/24/2014.
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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