Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therape…
- Recall date
- April 27, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0923-2017
- FDA classification
- Class III
- Brand / firm
- Noven Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide within US
Why it was recalled
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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