FDA recall D-0008-2019

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

Reason for recall

CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Distribution

Distributed to two compounding firms in Minnesota.

Key facts

Status

Terminated

Initiation date

2018-08-30

Report date

2018-10-17

Termination date

2019-02-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Glendale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0008-2019