Multi-event July 2021 FDA Recall Combipatch
estradiol/norethindrone Acetate Transdermal System by Noven Pharmaceuticals Inc
This Multi-event Class II drug recall was voluntarily initiated by Noven Pharmaceuticals Inc on July 30, 2021 for the product Combipatch (estradiol/norethindrone Acetate Transdermal System). The FDA reported the reason for recall as failed stability specifications; out of specification for shear.. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0724-2021
Failed Stability Specifications; out of specification for shear.
07-30-2021
08-25-2021
223,382 boxes
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Noven Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022
Recall Number: D-0725-2021
Failed Stability Specifications; out of specification for shear.
07-30-2021
08-25-2021
70,638 boxes
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Noven Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lots: 88540 Exp. 03/2022; 89118 Exp. 05/2022; 89244 Exp. 07/2022; 89244 (sample lot) Exp. 07/2022
