Why it was recalled
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 76476; Exp 07/16
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0485-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 25, 2015
- FDA report date
- Apr 22, 2015
- Quantity
- 720 transdermal patches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0485-2015, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 70764
- Address
- 11960 Sw 144th St
- Code information
- Lot # 76476; Exp 07/16
- Postal code
- 33186-6109
- Report date
- Apr 22, 2015
- Product type
- Drugs
- Recall number
- D-0485-2015
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals, Inc.
- Product quantity
- 720 transdermal patches
- Termination date
- Feb 26, 2019
- Reason for recall
- Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 25, 2015
- Initial firm notification
- Letter
- Center classification date
- Apr 13, 2015