← FDA ENFORCEMENT
D-0081-2024Class II

Padagis US LLC

Recalling firm
Padagis US LLC
Product type
Drug
Status
Ongoing
Report date
2023-11-08
Distribution
Nationwide within the United States
Firm state
MN
Product quantity
10,512 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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.

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

Code / lot info

Lot#: 164185, Exp. Date 4/2024

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.