THYROID POWDER USP : labeled range of 8 recalled over manufacturing violations

Recall date

August 22, 2018

Source

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

Official notice title

Syntec Pharma Corp recalls THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (correct spelling Liothyronine): lab…

Recall number

D-0014-2019

FDA classification

Class II

Brand / firm

Syntec Pharma Corp

Sold / distributed

Al & TX only

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 USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 8.1-9.9mcg/grain) active pharmaceutical ingredient; 25 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hongpai Road, Neijiang, sichuan 641000, china; Distributed: Syntec Pharma Corp., 96 Gazza Blvd., Farmingdale NY 11735, CAS No. 50809-32-0