The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0923-2017·Announced 2017-07-05

Noven Recalls Minivelle Estradiol Patches Due to Defective Delivery System

Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal systems because the delivery system failed stability testing for peel force.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Noven Pharmaceuticals, Inc. is recalling 14,434 cartons of Minivelle (estradiol) 0.1 mg per day transdermal systems. The recall involves Lot #78618 with an expiration date of 05/2017. The product was distributed nationwide within the United States.

The recall was initiated because the delivery system was found to be out of specification for peel force from the release liner during stability testing at 18 months under 25C/60%RH conditions. This defect relates to the physical integrity of the patch's delivery mechanism.

Consumers who have this specific lot of Minivelle should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product
MINIVELLE (ESTRADIOL)
Brand
MINIVELLE
Manufacturer
Noven Pharmaceuticals, Inc.
Category
Drug — Transdermal Patch
Hazard
Affected units
14,434

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #:: 78618
  • Exp. 05/2017

UPCs (1)

  • 0368968665083

Distribution

Distributed nationwide across the United States.

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