Drug product
Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298. NDC 7807-0170-11
D-0006-2019
Product summary
- Event
- Event 80892
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2662 kg
- Official record key
drug-enforcement:D-0006-2019
Official wording
Reason: CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Code information: All lots to include 160601, 160602, 160603, 160801, 161101, 162011, 170301, 170501, 170502, 170701, and 170702
Distribution pattern: Distributed nationwide and China
Derived failure modes
-
Manufacturing or process control
CGMP Deviations