Recalls / Class II
Class IID-0023-2019
Product
Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 100 grams NDC 0395-8077-62 Packaged by: Humco Texarkana, TX 75501 USA
- Affected lot / code info
- Lots: A24543 Exp. 02/2019; A25724 Exp. 01/2019; A25529 Exp. 04/2019; A25723 Exp. 04/2019; A27120 Exp. 05/2019; A27811 Exp. 06/2019; A28626 Exp. 06/2019; A29171 Exp. 06/2019; A29221 Exp. 06/2019
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
- Unknown.
- 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-0023-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.