D-0014-2019 Class II Terminated
FDA drug recall D-0014-2019 was initiated by Syntec Pharma Corp on Aug 22, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. The recall status is terminated (terminated Apr 22, 2024). Affected quantity: 486 kg.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 17, 2018
- Initiation Date
- Aug 22, 2018
- Termination Date
- Apr 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 486 kg
Product Description
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
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