Drug product
LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378181101.
D-898-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 499 Tablets
- Official record key
drug-enforcement:D-898-2014
Official wording
Reason: Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled as one of the following drugs: ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn), NDC 00904533260, Pedigree: AD57624_1, EXP: 5/9/2014; hydrALAZINE HCl, Tablet, 50 mg, NDC 50111032801, Pedigree: AD52778_28, EXP: 5/20/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W003828, EXP: 6/
Code information: LEVOTHYROXINE SODIUM, Tablet, 112 mcg has the following codes: Pedigree: AD60211_1, EXP: 5/21/2014; Pedigree: AD52778_37, EXP: 5/20/2014; Pedigree: W003847, EXP: 6/27/2014; Pedigree: AD30197_13, EXP: 5/9/2014; Pedigree: AD49423_7, EXP: 5/16/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled