Drug product
GUAIFENESIN, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904515460
D-477-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-477-2014
Official wording
Reason: Labeling: Label Mixup; GUAIFENESIN, Tablet, 200 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: W002850, EXP: 6/7/2014.
Code information: GUAIFENESIN, Tablet, 200 mg has the following code Pedigree: W002853, EXP: 6/7/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled