November 2019 FDA Recall Drug by Wisconsin Pharmacal Company, Llc
D-0781-2020 - cGMP violations

This Class II drug recall was voluntarily initiated by Wisconsin Pharmacal Company, Llc on November 14, 2019 for the product Drug. The FDA reported the reason for recall as cgmp violations. The product was distributed in OR and the recall is currently terminated.

Recall Number: D-0781-2020

Reason for Recall
cGMP violations
Initiated
11-14-2019
Reported
01-22-2020
Quantity
44,373 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84291
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wisconsin Pharmacal Company, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
OR
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration 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.