Drug product
ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505267109
D-662-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-662-2014
Official wording
Reason: Labeling:Label Mixup; ATORVASTATIN CALCIUM, Tablet, 80 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, 10 Billion Cells, NDC 49100036374, Pedigree: AD21965_19, EXP: 5/1/2014.
Code information: ATORVASTATIN CALCIUM, Tablet, 80 mg has the following code Pedigree: AD21965_4, EXP: 5/1/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled