Home / Recalls / Syntec Pharma Corp / D-0013-2019

D-0013-2019 Class II Terminated

Recalled by Syntec Pharma Corp — Farmingdale, NY

Recall Details

Product Type: Drugs
Report Date: October 17, 2018
Initiation Date: August 22, 2018
Termination Date: April 22, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 drums

Product Description

THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 24.3-29.7mcg/grain) active pharmaceutical ingredient; 5 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

Reason for Recall

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

Distribution Pattern

Al & TX only

Code Information

All lots