Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Fl

FDA recall notice · announced May 16, 2018 · Noven Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.

Reason for recall

Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot #: 81391, 81638 Exp. 10/18
Quantity: 61960 boxes
Status: Terminated
Products in this recall event:
- Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, F (D-0863-2018)
- Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Flor (D-0862-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.