FDAClass IIIJuly 5, 2017

Minivelle recall

Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida…

Why was Minivelle recalled?

Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #:: 78618, Exp. 05/2017

Product
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida…
Recalling firm
Noven Pharmaceuticals, Inc.
Quantity
14434 cartons
Distribution
Nationwide within US
Recall date
July 5, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls