The Recall Desk
SevereFDA (Drugs)·D-522-2014·Announced 2014-01-22

Pramipexole Tablets Recalled for Potential Mislabeling as Misoprostol

Aidapak Services is recalling Pramipexole tablets that may be mislabeled as Misoprostol. The error could lead to patients receiving 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury or adverse health consequences (such as receiving the wrong medication) are rated as Severe.

Plain-English summary

Aidapak Services, LLC is recalling Pramipexole Di-HCL Tablets, 1 mg, NDC 16714058701. The recall is due to a labeling error where the product may be mislabeled as Misoprostol, Tablet, 200 mcg, NDC 59762500801. The affected product has the pedigree W003150 and an expiration date of 6/13/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This labeling mixup poses a risk because patients may receive Misoprostol instead of Pramipexole, or vice versa, depending on how the mislabeled product is dispensed.

Patients and healthcare providers should check their medication labels and contact their pharmacist or prescriber if they have questions about the product. The recall is classified as FDA Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
PRAMIPEXOLE DI-HCL Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714058701
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
  • 1 mg has the following code Pedigree: W003150
  • EXP: 6/13/2014.

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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