FDA recall D-0022-2019

Humco Holding Group, Inc · Class II · drug

Product

Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-8077-43 Packaged by: Humco Texarkana, TX 75501

Reason for recall

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

Distribution

Nationwide.

Key facts

Status
Terminated
Initiation date
2018-08-28
Report date
2018-10-24
Termination date
2020-05-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Texarkana, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0022-2019