Drug product
ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378212277.
D-903-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 270 Tablets
- Official record key
drug-enforcement:D-903-2014
Official wording
Reason: Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 11845014882, Pedigree: AD70700_7, EXP: 5/29/2014; TACROLIMUS, Capsule, 0.5 mg, NDC 00781210201, Pedigree: W003169, EXP: 6/13/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD42584_1, EXP: 5/14/2014.
Code information: ATORVASTATIN CALCIUM, Tablet, 80 mg has the following codes: Pedigree: AD73627_1, EXP: 5/30/2014; Pedigree: W003213, EXP: 6/14/2014; Pedigree: AD46300_1, EXP: 5/15/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled