RecallRadar

FDA Drug recall D-569-2014

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

On 2014-01-22 the FDA classified a Class II recall of guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802049878 by Aidapak Services, citing 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; FENOFIBRAT….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-569-2014
ClassificationClass II
Statusterminated
Initiated2013-07-02
Published2014-01-22
Last updated2026-09-13 11:51 UTC
CompanyAidapak Services
DistributionAZ, CA, OR, WA

Product

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

Reason

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

Identifiers

code_info
guaiFENesin ER, Tablet, 600 mg has the following codes Pedigree: AD21790_58, EXP: 5/1/2014; Pedigree: W002734, EXP:…guaiFENesin ER, Tablet, 600 mg has the following codes Pedigree: AD21790_58, EXP: 5/1/2014; Pedigree: W002734, EXP: 6/6/2014; Pedigree: W003689, EXP: 6/26/2014; Pedigree: AD30140_37, EXP: 5/7/2014; Pedigree: W003006, EXP: 6/11/2014.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-569-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.