D-0296-2019 Class II Terminated

Recalled by LGM Pharma LLC — Erlanger, KY

Recall Details

Product Type
Drugs
Report Date
December 19, 2018
Initiation Date
August 24, 2018
Termination Date
September 11, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,307 kg

Product Description

Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1

Reason for Recall

CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Distribution Pattern

Nationwide in the USA

Code Information

Lots: 161101, EXP 11/2/2016; 161201, EXP Nov 2018; 170301, EXP Feb 2019; 170501, Exp Apr 2019; 170701, Exp Jun 2019