Drug recall D-0923-2017
Product
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8
Reason for recall
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Lots and codes
Lot #:: 78618, Exp. 05/2017
Recall details
- Recalling firm
- Noven Pharmaceuticals, Inc., Miami, FL
- Quantity
- 14434 cartons
- Distribution
- Nationwide within US
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 27, 2017
- Terminated
- March 11, 2019
Related products
- Minivelle – drug information
- NDC 68968-6650 Minivelle · Estradiol .05 mg/d · Noven Therapeutics, LLC
- NDC 68968-6610 Minivelle · Estradiol .1 mg/d · Noven Therapeutics, LLC
- NDC 68968-6675 Minivelle · Estradiol .075 mg/d · Noven Therapeutics, LLC
- NDC 68968-6625 Minivelle · Estradiol .025 mg/d · Noven Therapeutics, LLC
- NDC 68968-6637 Minivelle · Estradiol .0375 mg/d · Noven Therapeutics, LLC