guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802049878
Reported: January 22, 2014 Initiated: July 2, 2013 #D-569-2014
Product Description
guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802049878
Reason for Recall
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
Details
- Recalling Firm
- Aidapak Services, LLC
- Units Affected
- 500 Tablets
- Distribution
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Location
- Vancouver, WA
Frequently Asked Questions
What product was recalled? ▼
guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802049878. Recalled by Aidapak Services, LLC. Units affected: 500 Tablets.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 22, 2014. Severity: Moderate. Recall number: D-569-2014.
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