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
Reported: April 22, 2015 Initiated: February 25, 2015 #D-0485-2015
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
Reason for Recall
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Details
- Recalling Firm
- Noven Pharmaceuticals, Inc.
- Units Affected
- 720 transdermal patches
- Distribution
- Nationwide
- Location
- Miami, FL
Frequently Asked Questions
What product 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. Recalled by Noven Pharmaceuticals, Inc.. Units affected: 720 transdermal patches.
Why was this product recalled? ▼
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 22, 2015. Severity: Moderate. Recall number: D-0485-2015.
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