FDA Recalls Pramipexole Tablets Due to Potential Labeling Error
Aidapak Services, LLC is recalling Pramipexole Di-HCl tablets that may be mislabeled as Liothyronine Sodium. The error poses a risk of incorrect medication administration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) in the absence of reported serious injuries or fatalities, as it involves a risk of harm from incorrect medication administration.
Plain-English summary
Aidapak Services, LLC is recalling Pramipexole Di-HCl, 1.5 mg tablets (NDC 68462033490) due to a labeling mixup. The product may be potentially mislabeled as Liothyronine Sodium, 25 mcg tablets (NDC 42794001902). The affected product has the pedigree AD68010_20 and an expiration date of 5/28/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This 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.
Consumers and healthcare providers should check their inventory for the specific NDC and pedigree listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions about their medication.
The recalled product
- Product
- PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462033490
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Tablets
- Hazard
- 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 (4)
- PRAMIPEXOLE DI-HCL
- Tablet
- 1.5 mg has the following code Pedigree: AD68010_20
- EXP: 5/28/2014.
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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