RecallDepth
Class II Ongoing

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186

This recall is currently active, issued August 25, 2021. It was issued by Noven Pharmaceuticals, Inc..

Company
Noven Pharmaceuticals, Inc.
Recall Initiated
July 30, 2021
Posted
August 25, 2021
Recall Number
D-0724-2021
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
223,382 boxes
Firm Location
Miami, FL, United States
Official Source
View on FDA website ↗

Reason for Recall

Failed Stability Specifications; out of specification for shear.

Distribution

Nationwide.

Lot / Code Info

Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022

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