Recalls / Class II
Class IID-1209-2018
Product
Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8
- 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
- Lots: 82199 Exp. 12/2018; 83025 Exp. 05/2019
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
- 26217 boxes of 8 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-1209-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.