FDAClass IIJanuary 29, 2014

glyBURIDE recall: Labeling Error

glyBURIDE, Tablet, 1.25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093834201.

Why was glyBURIDE recalled?

Labeling: Label Mixup: glyBURIDE, Tablet, 1.25 mg may have potentially been mislabeled as one of the following drugs: CYPROHEPTADINE HCL, Tablet, 4 mg, NDC 60258085001, Pedigree: W003676, EXP: 6/25/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: AD21790_1, EXP: 5/1/2014.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

glyBURIDE, Tablet, 1.25 mg has the following codes: Pedigree: W003677, EXP: 2/28/2014; Pedigree: AD21790_10, EXP: 2/28/2014.

Product
glyBURIDE, Tablet, 1.25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093834201.
Recalling firm
Aidapak Services, LLC
Quantity
200 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls