Class I · High risk
Thyroid Tablets
Superpotent Drug
Thyroid Powder USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Drug: Levothyroxine Category: Thyroid Medication
- Recalling firm
- Syntec Pharma Corp
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0013-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Levothyroxine recalls
See all
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug
Other recalls by Syntec Pharma Corp
All 2018 recalls
Class II · Moderate risk
Thyroid Powder USP
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.