FDA Recall D-0081-2024

Padagis US LLC · Minneapolis, MN

Class II Ongoing 959 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot#: 164185, Exp. Date 4/2024

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 record

Recall number: D-0081-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2023-09-28
Classified by FDA Center: 2023-10-31
FDA published: 2023-11-08
Recalling firm: Padagis US LLC
Firm location: Minneapolis, MN

Drug identification

Brand name(s): GYNAZOLE 1
Generic name(s): BUTOCONAZOLE NITRATE
Manufacturer(s): Padagis Israel Pharmaceuticals Ltd
NDC(s): 45802-396
Route(s): VAGINAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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