Recalls / Class II
Class IID-1207-2018
Product
Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8
- Brand name
- Minivelle
- Generic name
- Estradiol
- Active ingredient
- Estradiol
- Route
- Transdermal
- NDCs
- 68968-6610, 68968-6625, 68968-6637, 68968-6650, 68968-6675
- FDA application
- NDA203752
- Affected lot / code info
- a) 82200 Exp. 01/2019 b) 81637 Exp. 10/2018; 82200 Exp. 01/2019; 82293 Exp. 02/2019; 82600 Exp. 04/2019; 83027 Exp. 04/2019; 83173 Exp. 06/2019; 83396 Exp. 09/2019
Why it was recalled
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Recalling firm
- Firm
- Noven Pharmaceuticals, Inc.
- Manufacturer
- Noven Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11960 SW 144th St, Miami, Florida 33186-6109
Distribution
- Quantity
- 213714 boxes of 8 patches and 15927 boxes of 2 patches
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-09-07
- FDA classified
- 2018-09-25
- Posted by FDA
- 2018-10-03
- Terminated
- 2020-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1207-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.