Aidapak Recalls Dutasteride Capsules Due to Potential Labeling Mixup
Aidapak Services, LLC is recalling 0.5 mg Dutasteride capsules because they may have been mislabeled as other medications. The repacked drugs were distributed in four western states.
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 due to a labeling mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries are categorized as Moderate.
Plain-English summary
Aidapak Services, LLC is recalling 270-count bottles of 0.5 mg Dutasteride capsules (NDC 00173071204) due to a labeling mixup. The recall is initiated because the product may have been incorrectly labeled as Docusate Sodium 250 mg capsules or Pyridoxine HCL 50 mg tablets.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall covers specific pedigree codes and expiration dates, including AD65475_1 (EXP 5/28/2014), AD54519_1 (EXP 5/21/2014), and W003247 (EXP 6/17/2014).
Consumers who have these specific bottles should stop using the medication and contact their healthcare provider or pharmacist for guidance. The FDA has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- DUTASTERIDE, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00173071204.
- 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)
- DUTASTERIDE
- Capsule
- 0.5 mg has the following codes: Pedigree: AD65475_1
- EXP: 5/28/2014
- Pedigree: AD54519_1
- EXP: 5/21/2014
- Pedigree: W003247
- EXP: 6/17/2014.
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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