Why it was recalled
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
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
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Al & TX only
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0013-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2018
- FDA report date
- Oct 17, 2018
- Quantity
- 2 drums
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Syntec Pharma Corp
Original FDA data
Every field from FDA enforcement report D-0013-2019, exactly as published.
Show all FDA fields
- City
- Farmingdale
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 81128
- Address
- 96 Gazza Blvd
- Code information
- All lots
- Postal code
- 11735-1402
- Report date
- Oct 17, 2018
- Product type
- Drugs
- Recall number
- D-0013-2019
- Classification
- Class II
- Recalling firm
- Syntec Pharma Corp
- Product quantity
- 2 drums
- Termination date
- Apr 22, 2024
- Reason for recall
- CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Al & TX only
- Recall initiation date
- Aug 22, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 11, 2018