FDA-Drug2014-01-22Class II

guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802049878

Aidapak Services, LLC
Hazard

Labeling: Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as FENOFIBRATE, Tablet, 54 mg, NDC 00378710077, Pedigree: AD21790_52, EXP: 5/1/2014; FENOFIBRATE, Tablet, 54 mg, NDC 00378710077, Pedigree: W002733, EXP: 6/6/2014; glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: W003688, EXP: 5/31/2014; glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: AD30140_34, E

Sold states
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Affected count
500 Tablets
Manufactured in
14301 Se 1st St, Vancouver, WA, United States
Products
guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802049878

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-569-2014

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