Farmingdale, NY, United States
Syntec Pharma Corp recalls
1 recall recorded since 2018, most recently on 22 August 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 22 August 2018
- Terminated
- 22 April 2024
- Reason
- CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
- Distribution
- Al & TX only
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0014-2019, D-0013-2019
- 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, Man
- 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 Compoun
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.