Aidapak Recalls Pramipexole Tablets Due to Potential Labeling Errors
Aidapak Services, LLC is recalling Pramipexole Di-HCl tablets because they may be mislabeled as Multivitamin/Multimineral or Perphenazine.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity level.
Plain-English summary
Aidapak Services, LLC is recalling Pramipexole Di-HCl, 0.125 mg tablets (NDC 13668009190) due to a labeling mixup. The recall involves 359 tablets that were repacked and distributed in Arizona, California, Oregon, and Washington. The affected products have pedigree codes AD25264_10 (expiration 5/3/2014) and W003683 (expiration 6/25/2014).
The recall was initiated because the Pramipexole tablets may be potentially mislabeled as Multivitamin/Multimineral tablets (NDC 00904549213, pedigree AD23082_13, expiration 11/1/2013) or Perphenazine tablets (NDC 00781104901, pedigree W003682, expiration 6/25/2014). This classification is designated as Class II by the FDA.
Patients and healthcare providers should verify the labeling of their medications. If the product matches the specific NDC, pedigree, and expiration dates listed above, it should be returned to the pharmacy or recalled firm for replacement or refund.
The recalled product
- Product
- PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668009190
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Tablets
- Hazard
- Affected units
- 359
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 (6)
- PRAMIPEXOLE DI-HCL
- Tablet
- 0.125 mg has the following codes Pedigree: AD25264_10
- EXP: 5/3/2014
- Pedigree: W003683
- EXP: 6/25/2014.
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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