Recalls / Class II
Class IID-0485-2015
Product
Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida 33186, NDC 68968-6650-8
- 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
- Lot # 76476; Exp 07/16
Why it was recalled
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Recalling firm
- Firm
- Noven Pharmaceuticals, Inc.
- Manufacturer
- Noven Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11960 Sw 144th St, N/A, Miami, Florida 33186-6109
Distribution
- Quantity
- 720 transdermal patches
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-02-25
- FDA classified
- 2015-04-13
- Posted by FDA
- 2015-04-22
- Terminated
- 2019-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0485-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.