US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 2, 2013 (13 years ago)

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

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
Aidapak Services, LLC
Origin
WA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-569-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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