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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- 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
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.
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