Drug product
LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378180701.
D-897-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 600 Tablets
- Official record key
drug-enforcement:D-897-2014
Official wording
Reason: Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as one of the following drugs: NEBIVOLOL HCL, Tablet, 5 mg, NDC 00456140530, Pedigree: AD73611_7, EXP: 5/30/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: W003022, EXP: 6/12/2014; ISOSORBIDE DINITRATE, Tablet, 5 mg, NDC 00781163501, Pedigree: W003474, EXP: 6/20/2014; HYDROCORTISONE, Tabl
Code information: LEVOTHYROXINE SODIUM, Tablet, 88 mcg has the following codes: Pedigree: AD73652_10, EXP: 5/30/2014; Pedigree: W003047, EXP: 6/12/2014; Pedigree: W003476, EXP: 6/20/2014; Pedigree: W002967, EXP: 6/11/2014; Pedigree: AD42584_1, EXP: 5/14/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled