April 28, 2021
Noven Pharmaceuticals Inc. is recalling two lots of branded and generic estradiol transdermal systems over concerns the patches may not adhere well to skin, according to the April 28, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were manufactured by Noven Pharmaceuticals, Miami, FL, and distributed by Noven Therapeutics, Miami, FL, throughout the United States:
- Minivelle (estradiol transdermal system), delivers 0.075 mg/day, 8 patches/box (NDC 68968-6675-8), from lot 88584 (Exp. 03/22), and
- estradiol transdermal system, delivers 0.0375 mg/day, 8 systems/box (NDC 68968-3437-8), from lot 88321 (Exp. 2/22).
Noven Pharmaceuticals voluntarily initiated the recall April 16, 2021. The FDA designated the recall Class II on April 20, 2021, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Transdermal estradiol is available with a prescription. The medication is female hormone used to reduce menopause symptoms in women.