Drug product
Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1
D-0296-2019
Product summary
- Firm
- LGM Pharma LLC
- Event
- Event 81606
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,307 kg
- Official record key
drug-enforcement:D-0296-2019
Official wording
Reason: CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Code information: Lots: 161101, EXP 11/2/2016; 161201, EXP Nov 2018; 170301, EXP Feb 2019; 170501, Exp Apr 2019; 170701, Exp Jun 2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations