Aidapak Recalls glyBURIDE Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling glyBURIDE tablets because they may have been mislabeled as CYPROHEPTADINE HCL or AMANTADINE HCL.
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 error (label mixup) without reported injuries, fitting the criteria for moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling glyBURIDE, Tablet, 1.25 mg (NDC 00093834201) due to a potential label mixup. The recalled product may have been mislabeled as CYPROHEPTADINE HCL, Tablet, 4 mg (NDC 60258085001) or AMANTADINE HCL, Capsule, 100 mg (NDC 00781204801).
The affected glyBURIDE tablets were repacked and distributed in Arizona, California, Oregon, and Washington. The specific lots involved have pedigree codes W003677 and AD21790_10, with an expiration date of 2/28/2014.
Patients and healthcare providers should check their medication labels to ensure they are taking the correct drug. If a patient has received medication that appears to be mislabeled, they should contact their pharmacist or physician for guidance.
The recalled product
- Product
- glyBURIDE, Tablet, 1.25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093834201.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 200
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)
- glyBURIDE
- Tablet
- 1.25 mg has the following codes: Pedigree: W003677
- EXP: 2/28/2014
- Pedigree: AD21790_10
- EXP: 2/28/2014.
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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