Drug product
THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 24.3-29.7mcg/grain) active pharmaceutical ingredient; 5 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hongpai Road, Neijiang, sichuan 641000, china; Distributed: Syntec Pharma Corp., 96 Gazza Blvd., Farmingdale NY 11735, CAS No. 50809-32-0
D-0013-2019
Product summary
- Event
- Event 81128
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 drums
- Official record key
drug-enforcement:D-0013-2019
Official wording
Reason: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Code information: All lots
Distribution pattern: Al & TX only
Derived failure modes
-
Manufacturing or process control
CGMP Deviations