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
Reported: July 5, 2017 Initiated: April 27, 2017 #D-0923-2017
Product Description
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.
Details
- Recalling Firm
- Noven Pharmaceuticals, Inc.
- Units Affected
- 14434 cartons
- Distribution
- Nationwide within US
- Location
- Miami, FL
Frequently Asked Questions
What product 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. Recalled by Noven Pharmaceuticals, Inc.. Units affected: 14434 cartons.
Why was this product recalled? ▼
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 5, 2017. Severity: Low. Recall number: D-0923-2017.
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