January 24, 2020
Citing Current Good Manufacturing Practice (cGMP) violations, Wisconsin Pharmacal Company is recalling 44,373 cartons of Yeast Arrest vaginal suppositories manufactured for Vitanica and distributed in Oregon. The recall was included in the January 22, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects Yeast Arrest, homeopathic formula, vaginal support suppositories packaged in:
- 14-count cartons (NDC 68093-0730-1, NDC 68093-0730-3) from lots 81827 (Exp. 8/20), 111872 (Exp. 11/20), 41970 (Exp. 4/21), and 519104 (Exp. 5/21); and
- 28-count cartons (NDC 68093-0730-2, NDC 68093-0730-4) from lots 81827 (Exp. 8/20), 111872 (Exp. 11/20), and 41970 (Exp 4/21).
Wisconsin Pharmacal Company voluntarily initiated the recall November 14, 2019. The FDA designated the recall Class II on January 16, 2020. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Yeast Arrest is a homeopathic product marketed to relieve symptoms associated with vaginal yeast infections.