Drug product
ATORVASTATIN CALCIUM, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378212177 .
D-902-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 810 Tablets
- Official record key
drug-enforcement:D-902-2014
Official wording
Reason: Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 40 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: AD33897_4, EXP: 5/9/2014; FINASTERIDE, Tablet, 5 mg, NDC 16714052201, Pedigree: W003031, EXP: 2/28/2014.
Code information: ATORVASTATIN CALCIUM, Tablet, 40 mg has the following codes: Pedigree: AD33897_10, EXP: 5/9/2014; Pedigree: W003096, EXP: 6/13/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled