September 2023 FDA Recall Gynazole 1 by Padagis Us Llc
D-0081-2024 - Incorrect Product Formulation

This Class II drug recall was voluntarily initiated by Padagis Us Llc on September 28, 2023 for the product Gynazole 1. The FDA reported the reason for recall as incorrect product formulation. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0081-2024

Reason for Recall
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Initiated
09-28-2023
Reported
11-08-2023
Quantity
10,512 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93189
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Padagis US 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.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01

Batch or Lot Expiration Information

Lot# : 164185, Exp. Date 4/2024

Affected Packages Involved in this Recall

45802-396-01 Gynazole 1
45802-396-02 Gynazole 1