Drug product
guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802049878
D-569-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 Tablets
- Official record key
drug-enforcement:D-569-2014
Official wording
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
Code information: 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.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled