Drug product
LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527134401.
D-921-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-921-2014
Official wording
Reason: Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as the following drug: guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: W003007, EXP: 6/12/2014.
Code information: LEVOTHYROXINE SODIUM, Tablet, 88 mcg has the following codes: Pedigree: W003010, EXP: 6/12/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled