Drug product
guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000850
D-684-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 Tablets
- Official record key
drug-enforcement:D-684-2014
Official wording
Reason: Labeling:Label Mixup; guaiFENesin ER Tablet, 600 mg may be potentially mislabeled as OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003243, EXP: 6/17/2014.
Code information: guaiFENesin ER, Tablet, 600 mg has the following code Pedigree: W003244, EXP: 6/17/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled