Drug product
LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527135001.
D-923-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-923-2014
Official wording
Reason: Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD46265_34, EXP: 5/15/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003008, EXP: 6/11/2014.
Code information: LEVOTHYROXINE SODIUM, Tablet, 175 mcg has the following codes: Pedigree: AD46265_37, EXP: 5/15/2014; Pedigree: W003009, EXP: 6/11/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled