Drug product
Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, 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-0008-2019
Product summary
- Event
- Event 81147
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 kgs
- Official record key
drug-enforcement:D-0008-2019
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: Lot # 170501
Distribution pattern: Distributed to two compounding firms in Minnesota.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations