Aidapak Recalls Mislabeled glyBURIDE Tablets Due to Labeling Error
Aidapak Services, LLC is recalling glyBURIDE tablets that may have been mislabeled as other prescription drugs. The error poses a risk of patients receiving incorrect 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, which corresponds to a Severe severity score under the rubric, particularly given the risk of patients receiving incorrect prescription medications.
Plain-English summary
Aidapak Services, LLC is voluntarily recalling glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, due to a labeling error. The recall is classified as FDA Class II. The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington.
The glyBURIDE tablets may have been mislabeled as sulfaSALAzine, ENTECAVIR, RALTEGRAVIR, or carBAMazepine ER. This label mixup could result in patients receiving a different medication than prescribed, which may lead to ineffective treatment or adverse health effects.
Patients and healthcare providers should check their medication labels and contact their pharmacist or physician if they have received glyBURIDE tablets with incorrect labeling. The recall is limited to specific pedigree codes and expiration dates listed in the official FDA notice.
The recalled product
- Product
- glyBURIDE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093834301.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 500
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 (10)
- glyBURIDE
- Tablet
- 2.5 mg has the following codes: Pedigree: AD46265_22
- EXP: 5/15/2014
- Pedigree: W003688
- EXP: 5/31/2014
- Pedigree: AD21790_55
- EXP: 5/1/2014
- Pedigree: AD30140_34
- EXP: 5/7/2014.
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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