The Recall Desk
SevereFDA (Drugs)·D-521-2014·Announced 2014-01-22

Pramipexole Tablets Recalled for Potential Label Mixup with Tacrolimus

Aidapak Services is recalling Pramipexole tablets that may be mislabeled as Tacrolimus capsules. The error could lead to patients taking the wrong medication.

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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the risk of administering the wrong medication.

Plain-English summary

Aidapak Services, LLC is recalling Pramipexole Di-HCL tablets, 0.25 mg, NDC 16714058501. The recall is due to a labeling error where the product may be mislabeled as Tacrolimus capsules, 1 mg, NDC 00781210301. The affected product has pedigree W003761 and an expiration date of 6/26/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This labeling mixup poses a risk of patients receiving or taking the wrong medication, which could result in incorrect treatment for their conditions.

Patients and healthcare providers should check their medication labels and contact their pharmacist or physician if they have received Pramipexole tablets that are labeled as Tacrolimus capsules. Do not take the medication if there is any doubt about its identity.

The recalled product

Product
PRAMIPEXOLE DI-HCL Tablet, 0.25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714058501
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 (3)

  • PRAMIPEXOLE DI-HCL Tablet
  • 0.25 mg has the following code Pedigree: W003761
  • EXP: 6/26/2014.

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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