Drug product
LIOTHYRONINE SODIUM, Tablet, 25 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574022201.
D-957-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Tablets
- Official record key
drug-enforcement:D-957-2014
Official wording
Reason: Labeling: Label Mixup: LIOTHYRONINE SODIUM, Tablet, 25 mcg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 175 mcg, NDC 00378181701, Pedigree: W003151, EXP: 6/13/2014; HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: W003000, EXP: 6/11/2014.
Code information: LIOTHYRONINE SODIUM, Tablet, 25 mcg has the following codes: Pedigree: W003152, EXP: 4/30/2014; Pedigree: W003001, EXP: 4/30/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled