FDA recall D-853-2014

Aidapak Services, LLC · Class II · drug

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-29
Termination date: 2014-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vancouver, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-853-2014