Drug product
Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count carton (NDC 68093-0730-1 and 68093-0730-3), b) 28-count carton (NDC 68093-0730-2 and 68093-0730-4), Manufactured for: Vitanica, 12401 SW Leveton Drive, Tualatin, OR 97062.
D-0781-2020
Product summary
- Event
- Event 84291
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44,373 cartons
- Official record key
drug-enforcement:D-0781-2020
Official wording
Reason: cGMP violations
Code information: Lot #: a) 81827, Exp 8/2020; 111872, Exp 11/2020; 41970, Exp 4/2021; 519104, Exp 5/2021; b) 81827, Exp 8/2020; 111872, Exp 11/2020; 41970, Exp 4/2021.
Distribution pattern: OR
Derived failure modes
-
Manufacturing or process control
cGMP violations