Aidapak Recalls Glyburide Tablets Due to Potential Label Mixup
Aidapak Services is recalling glyBURIDE MICRONIZED tablets because they may have been mislabeled as digoxin. The error could lead to patients receiving the wrong 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 involves a potential for temporary or medically reversible adverse health consequences. A label mixup between two distinct prescription drugs (glyburide and digoxin) carries a significant risk of incorrect medication administration, justifying a Severe rating.
Plain-English summary
Aidapak Services, LLC is recalling glyBURIDE MICRONIZED tablets, 3 mg, NDC 00093803501. The recall is due to a labeling error where the product may have been mislabeled as DIGOXIN tablets, 0.125 mg, NDC 00115981101. The affected glyBURIDE MICRONIZED tablets have pedigree W003155 and an expiration date of 6/13/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This labeling mixup poses a risk because glyburide and digoxin are different medications with distinct therapeutic uses and safety profiles. Patients or healthcare providers may inadvertently administer or dispense the wrong drug if the labels are incorrect.
Consumers and healthcare providers should check their inventory for glyBURIDE MICRONIZED tablets with the specified pedigree and expiration date. If found, these products should be quarantined and returned to the distributor or manufacturer for credit. Patients should consult their healthcare provider if they have received or taken the affected product.
The recalled product
- Product
- glyBURIDE MICRONIZED, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093803501.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 101
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)
- glyBURIDE MICRONIZED
- Tablet
- 3 mg has the following codes: Pedigree: W003155
- 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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