Drug Enforcement D-0081-2024

Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.

Status

Ongoing

Classification

Class II

Report Date

November 8, 2023

Termination Date

—

Product Information

Product description
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
Product quantity
10,512 cartons
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Padagis US LLC
Address
3940 Quebec Ave N, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0081-2024
Event ID
93189
Recall initiation date
September 28, 2023
Center classification date
October 31, 2023
Code info
Lot#: 164185, Exp. Date 4/2024
More code info
—