FDAClass IIOctober 3, 2018

Minivelle recall

Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc.…

Why was Minivelle recalled?

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

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?

a) 82292 Exp. 02/2019; b) 82139 Exp. 10/2018; 82292 Exp. 02/2019; and 82598 Exp. 04/2019

Product
Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc.…
Recalling firm
Noven Pharmaceuticals, Inc.
Quantity
149631 boxes of 8 patches and 15809 boxes of 2 patches
Distribution
Nationwide
Recall date
October 3, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls