PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: October 17, 2018 Initiated: August 30, 2018 #D-0008-2019

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

Reason for Recall

CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Details

Recalling Firm
Alkano Chemicals, Inc
Units Affected
8 kgs
Distribution
Distributed to two compounding firms in Minnesota.
Location
Glendale, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by Alkano Chemicals, Inc. Units affected: 8 kgs.
Why was this product recalled?
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 17, 2018. Severity: Moderate. Recall number: D-0008-2019.