FDA Recall D-0725-2021

Noven Pharmaceuticals Inc · Miami, FL

Class II Ongoing 1749 days on record

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

Product

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186

Lot / code: Lots: 88540 Exp. 03/2022; 89118 Exp. 05/2022; 89244 Exp. 07/2022; 89244 (sample lot) Exp. 07/2022

Quantity: 70,638 boxes

Reason for recall

Failed Stability Specifications; out of specification for shear.

Recall record

Recall number: D-0725-2021
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide.
Recall initiated: 2021-07-30
Classified by FDA Center: 2021-08-13
FDA published: 2021-08-25
Recalling firm: Noven Pharmaceuticals Inc
Firm location: Miami, FL

Drug identification

Brand name(s): COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
Generic name(s): ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM
Manufacturer(s): Noven Therapeutics, LLC
NDC(s): 68968-0514, 68968-0525
Route(s): TRANSDERMAL

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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