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  3. Recall Enforcement Event ID: 87741

Recall Enforment Report D-0337-2021

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Noven Pharmaceuticals Inc, originally initiated on 04-16-2021 for the product Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-3437-8 The product was recalled due to defective delivery system: out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. as a result, patients could experience patches that do not stick well to the skin.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0337-202104-16-202104-28-2021Class II10872 cartonsEstradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-3437-8Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.Terminated
D-0336-202104-16-202104-28-2021Class II12060 cartonsMinivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
68968-3410Estradiol EstradiolFilm, Extended ReleaseTransdermalNoven Therapeutics, LlcHuman Prescription Drug
68968-3425Estradiol EstradiolFilm, Extended ReleaseTransdermalNoven Therapeutics, LlcHuman Prescription Drug
68968-3437Estradiol EstradiolFilm, Extended ReleaseTransdermalNoven Therapeutics, LlcHuman Prescription Drug
68968-3450Estradiol EstradiolFilm, Extended ReleaseTransdermalNoven Therapeutics, LlcHuman Prescription Drug
68968-3475Estradiol EstradiolFilm, Extended ReleaseTransdermalNoven Therapeutics, LlcHuman Prescription Drug
68968-6610Minivelle EstradiolFilm, Extended ReleaseTransdermalNoven Therapeutics, LlcHuman Prescription Drug
68968-6625Minivelle EstradiolFilm, Extended ReleaseTransdermalNoven Therapeutics, LlcHuman Prescription Drug
68968-6637Minivelle EstradiolFilm, Extended ReleaseTransdermalNoven Therapeutics, LlcHuman Prescription Drug
68968-6650Minivelle EstradiolFilm, Extended ReleaseTransdermalNoven Therapeutics, LlcHuman Prescription Drug
68968-6675Minivelle EstradiolFilm, Extended ReleaseTransdermalNoven Therapeutics, LlcHuman Prescription Drug