The Recall Desk
SevereFDA (Drugs)·D-720-2014·Announced 2014-01-22

Aidapak Recalls Selegiline HCL Capsules Due to Potential Labeling Mixup

Aidapak Services, LLC is recalling Selegiline HCL 5 mg capsules because they may be mislabeled as Itraconazole 100 mg. The repacked drugs were distributed in four western states.

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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as taking the wrong medication) are rated as Severe (4), especially given the strict rule that FDA Class I/II classifications generally warrant a score of 4 or higher when significant risks are implied.

Plain-English summary

Aidapak Services, LLC is recalling Selegiline HCL, Capsule, 5 mg, NDC 67253070006, due to a labeling mixup. The product, which is a prescription-only medication, may be potentially mislabeled as Itraconazole, Capsule, 100 mg, NDC 10147170003. The specific pedigree for the recalled Selegiline HCL is AD54549_19, with an expiration date of 5/20/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should check their inventory for Selegiline HCL 5 mg capsules with the specified pedigree and expiration date. If found, the product should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding their medication.

The recalled product

Product
SELEGILINE HCL, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67253070006
Affected units
60

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)

  • SELEGILINE HCL
  • Capsule
  • 5 mg has the following code Pedigree: AD54549_19
  • EXP: 5/20/2014.

Distribution

Distributed in 4 states:

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.

See all 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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