Drug product
ATORVASTATIN CALCIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505257909
D-661-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-661-2014
Official wording
Reason: Labeling:Label Mixup; ATORVASTATIN CALCIUM Tablet, 20 mg may be potentially mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003850, EXP: 6/27/2014.
Code information: ATORVASTATIN CALCIUM, Tablet, 20 mg has the following code Pedigree: W003846, EXP: 6/27/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled