Thyroid powder recalled over manufacturing violations

Recall date

August 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Alkano Chemicals, Inc recalls Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, Thyroid Powder 25kg/drum, US Pharmacopoei…

Recall number

D-0008-2019

FDA classification

Class II

Brand / firm

Alkano Chemicals, Inc

Sold / distributed

Distributed to two compounding firms in Minnesota.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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