Why it was recalled
CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Product description
Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298. NDC 7807-0170-11
Lot numbers, UPCs & expiration codes
All lots to include 160601, 160602, 160603, 160801, 161101, 162011, 170301, 170501, 170502, 170701, and 170702
Where it was sold
Distributed nationwide and China
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-0006-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 21, 2018
- FDA report date
- Oct 10, 2018
- Quantity
- 2662 kg
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sichuan Friendly Pharmaceutical Co.,Ltd.
Original FDA data
Every field from FDA enforcement report D-0006-2019, exactly as published.
Show all FDA fields
- City
- Neijiang
- Status
- Terminated
- Country
- China
- Event ID
- 80892
- Address
- No. 680 Hongpai Road
- Address (line 2)
- Dongxing
- Code information
- All lots to include 160601, 160602, 160603, 160801, 161101, 162011, 170301, 170501, 170502, 170701, and 170702
- Report date
- Oct 10, 2018
- Product type
- Drugs
- Recall number
- D-0006-2019
- Classification
- Class II
- Recalling firm
- Sichuan Friendly Pharmaceutical Co.,Ltd.
- Product quantity
- 2662 kg
- Termination date
- Jul 7, 2025
- Reason for recall
- CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298. NDC 7807-0170-11
- Distribution pattern
- Distributed nationwide and China
- Recall initiation date
- Aug 21, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 2, 2018