The Recall Desk
SevereFDA (Drugs)·D-854-2014·Announced 2014-01-29

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
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

Distributed in 4 states:

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.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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