Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8
Reported: October 3, 2018 Initiated: September 7, 2018 #D-1209-2018
Product Description
Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8
Reason for Recall
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Details
- Recalling Firm
- Noven Pharmaceuticals, Inc.
- Units Affected
- 26217 boxes of 8 patches
- Distribution
- Nationwide
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8. Recalled by Noven Pharmaceuticals, Inc.. Units affected: 26217 boxes of 8 patches.
Why was this product recalled? ▼
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 3, 2018. Severity: Moderate. Recall number: D-1209-2018.
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