Drug product
ATORVASTATIN CALCIUM, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378201777.
D-901-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 811 Tablets
- Official record key
drug-enforcement:D-901-2014
Official wording
Reason: Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 20 mg may have potentially been mislabeled as one of the following drugs: COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD32325_4, EXP: 5/9/2014; ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: AD49582_7, EXP: 5/16/2014.
Code information: ATORVASTATIN CALCIUM, Tablet, 20 mg has the following codes: Pedigree: AD33897_7, EXP: 5/9/2014; Pedigree: AD49582_10, EXP: 5/16/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled