October 04, 2018
Minivelle (estradiol transdermal system) patches are being recalled by Noven Pharmaceuticals Inc. because their delivery system may be defective, according to the October 3, 2018, US Food and Drug Administration (FDA) Enforcement Report. Samples of the transdermal patches tested out of specification for shear, an attribute related to adhesion.
The recall includes the following products, which were distributed across the United States:
- Minivelle 0.025 mg/day (NDC 68968-6625-8) 8-count boxes from lots 82199 (Exp. 12/18) and 83025 (Exp. 5/19);
- Minivelle 0.05 mg/day (NDC 68968-6650-8) 2-count boxes from lot 82292 (Exp. 2/19) and 8-count boxes from lots 82139 (Exp. 10/18), 82292 (Exp. 2/19), and 82598 (Exp. 4/19);
- Minivelle 0.075 mg/day (NDC 68968-6675-8) 8-count boxes from lots 82599 (Exp. 5/19), 82660 (Exp. 3/19), and 83396 (Exp. 9/19); and
- Minivelle 0.1 mg (NDC 68968-6610-8) 2-count boxes from lot 82200 (Exp. 1/19) and 8-count boxes from lots 81637 (Exp. 10/18), 82200 (Exp. 1/19), 82293 (Exp. 2/19), 82600 (Exp. 4/19), 83027 (Exp. 4/19), 83173 (Exp. 6/19), and 83396 ( Exp. 9/19).
Noven Pharmaceuticals voluntarily initiated the recall September 7, 2018. On September 25, 2018, the FDA designated it Class II. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Minivelle is a prescription estradiol patch used to treat hot flashes in menopause and to help prevent postmenopausal osteoporosis.
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