Drug product
LEVOTHYROXINE SODIUM, Tablet, 137 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781519192.
D-1010-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-1010-2014
Official wording
Reason: Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 137 mcg may have potentially been mislabeled as the following drug: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD21846_1, EXP: 5/1/2014.
Code information: LEVOTHYROXINE SODIUM, Tablet, 137 mcg has the following codes: Pedigree: AD22616_10, EXP: 5/2/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled