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
D-0022-2019
Product summary
- Event
- Event 81061
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0022-2019
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: Lots: A24542 Exp. 02/2019; A25528 Exp. 04/2019; A27119 Exp. 05/2019; A27810 Exp. 06/2019
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations