Pregabalin Capsules Recalled for Potential Labeling Mixup
Aidapak Services is recalling Pregabalin 25 mg capsules because they may have been mislabeled as Cholecalciferol or Glyburide.
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 fall under the Moderate severity category.
Plain-English summary
Aidapak Services, LLC is recalling Pregabalin, Capsule, 25 mg, NDC 00071101268. The recall is due to a labeling mixup where the product may have been mislabeled as Cholecalciferol, Capsule, 2000 units, or Glyburide Micronized, Tablet, 3 mg.
The affected Pregabalin capsules were distributed in Arizona, California, Oregon, and Washington. The specific pedigree codes and expiration dates for the recalled Pregabalin are W003777 (EXP: 6/26/2014) and W003121 (EXP: 6/13/2014). The source text does not specify the total number of units recalled.
Consumers and healthcare providers should check their inventory for these specific NDCs and pedigree codes. If the product is found, it should be returned to the distributor or a local pharmacy for replacement or refund. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- PREGABALIN, Capsule, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071101268.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 180
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)
- PREGABALIN
- Capsule
- 25 mg has the following codes: Pedigree: W003777
- EXP: 6/26/2014
- Pedigree: W003121
- EXP:6/13/2014.
Distribution
Part of a larger recall action
This product is one of 265 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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