Drug product
ATORVASTATIN CALCIUM, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378201577.
D-900-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 990 Tablets
- Official record key
drug-enforcement:D-900-2014
Official wording
Reason: Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: AD30180_4, EXP: 5/8/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD49399_4, EXP: 5/16/2014; ASPIRIN, CHEW Tablet, 81 mg, NDC 00536329736, Pedi
Code information: ATORVASTATIN CALCIUM, Tablet, 10 mg has the following codes: Pedigree: AD33897_4, EXP: 5/9/2014; Pedigree: AD49582_7, EXP: 5/16/2014; Pedigree: W002774, EXP: 6/6/2014; Pedigree: W003095, EXP: 6/12/2014;
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled