Recalls / Class II
Class IID-0024-2019
Product
Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-6580-43 Packaged by: Humco Texarkana, TX 75501 USA
- Affected lot / code info
- Lot: A26450 Exp. 05/2019
Why it was recalled
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Recalling firm
- Firm
- Humco Holding Group, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7400 Alumax Rd, N/A, Texarkana, Texas 75501-0282
Distribution
- Quantity
- 10 kilograms
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2018-08-28
- FDA classified
- 2018-10-12
- Posted by FDA
- 2018-10-24
- Terminated
- 2020-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0024-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.