Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by:…
- Recall date
- September 7, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1208-2018
- FDA classification
- Class II
- Brand / firm
- Noven Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
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) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8
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