The Recall Desk
SevereFDA (Drugs)·D-873-2014·Announced 2014-01-29

Dutasteride Capsules Recalled for Potential Labeling Mixup

Aidapak Services is recalling 0.5 mg dutasteride capsules because they may have been mislabeled as phenol, repaglinide, or cholecalciferol.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classifies this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when there is a risk of significant injury from receiving the wrong medication.

Plain-English summary

Aidapak Services, LLC is recalling 90-count bottles of 0.5 mg dutasteride capsules (NDC 00173071215) due to a potential labeling mixup. The recall affects specific lots with pedigree codes AD49610_1, AD70633_1, and AD52778_4, which have expiration dates of May 16, 2014, May 29, 2014, and May 20, 2014, respectively.

The FDA classifies this as a Class II recall because the dutasteride capsules may have been mislabeled as one of three other medications: 29 mg phenol lozenges, 2 mg repaglinide tablets, or 5000-unit cholecalciferol capsules. This error could lead to patients receiving the wrong medication.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Consumers and healthcare providers should check their medication labels and contact their pharmacist or physician if they have dutasteride capsules with the affected pedigree codes.

The recalled product

Product
DUTASTERIDE, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00173071215.
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 (8)

  • DUTASTERIDE
  • Capsule
  • 0.5 mg has the following codes: Pedigree: AD49610_1
  • EXP: 5/16/2014
  • Pedigree: AD70633_1
  • EXP: 5/29/2014
  • Pedigree: AD52778_4
  • EXP: 5/20/2014.

Distribution

Distributed in 4 states:

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.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

See all →