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, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, 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
Lot # 170501
Where it was sold
Distributed to two compounding firms in Minnesota.
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-0008-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 30, 2018
- FDA report date
- Oct 17, 2018
- Quantity
- 8 kgs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alkano Chemicals, Inc
Original FDA data
Every field from FDA enforcement report D-0008-2019, exactly as published.
Show all FDA fields
- City
- Glendale
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 81147
- Address
- 655 N Central Ave Fl 17 Ste 1704a
- Code information
- Lot # 170501
- Postal code
- 91203-1439
- Report date
- Oct 17, 2018
- Product type
- Drugs
- Recall number
- D-0008-2019
- Classification
- Class II
- Recalling firm
- Alkano Chemicals, Inc
- Product quantity
- 8 kgs
- Termination date
- Feb 21, 2019
- 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, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, 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 to two compounding firms in Minnesota.
- Recall initiation date
- Aug 30, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 5, 2018