Drug 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
D-0024-2019
Product summary
- Event
- Event 81061
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 kilograms
- Official record key
drug-enforcement:D-0024-2019
Official wording
Reason: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Code information: Lot: A26450 Exp. 05/2019
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations