Recalls / Class II

Class IID-854-2014

Product

glyBURIDE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093834301.

Affected lot / code info

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.

Why it was recalled

Labeling: Label Mixup: glyBURIDE, Tablet, 2.5 mg may have potentially been mislabeled as one of the following drugs: sulfaSALAzine, Tablet, 500 mg, NDC 59762500001, Pedigree: AD46265_13, EXP: 5/15/2014; ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: W003687, EXP: 6/26/2014; RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: AD21790_22, EXP: 5/1/2014; carBAMazepine ER, Tablet, 100 m

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

500 Tablets

Distribution pattern

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Timeline

Recall initiated

2013-07-02

FDA classified

2014-01-20

Posted by FDA

2014-01-29

Terminated

2014-02-07

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-854-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.