Minivelle 0 recalled over temperature-control failures
- Recall date
- February 25, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc.…
- Recall number
- D-0485-2015
- FDA classification
- Class II
- Brand / firm
- Noven Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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