Noven Pharmaceuticals, Inc.: Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186

Is my product affected?

Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8

• Brand MINIVELLE

Check against the official notice below — it lists the full affected range.

What happened

Noven Pharmaceuticals, Inc. is recalling Minivelle (estradiol transdermal system) patches that deliver 0.1 mg/day in both 2-count and 8-count boxes. The recall affects approximately 213,714 boxes of 8 patches and 15,927 boxes of 2 patches distributed nationwide. The patches are being recalled due to a defective delivery system with out-of-specification results for shear, which relates to the adhesive properties of the transdermal patches.

The affected lots include multiple batches with expiration dates ranging from October 2018 through September 2019, identified by lot codes 81637, 82200, 82293, 82600, 83027, 83173, and 83396. The source document does not specify what consumers should do if they have received or are using affected patches from these lots.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. Distribution: Nationwide Quantity: 213714 boxes of 8 patches and 15927 boxes of 2 patches Lot/code info: a) 82200 Exp. 01/2019 b) 81637 Exp. 10/2018; 82200 Exp. 01/2019; 82293 Exp. 02/2019; 82600 Exp. 04/2019; 83027 Exp. 04/2019; 83173 Exp. 06/2019; 83396 Exp. 09/2019

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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