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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Noven Pharmaceuticals Inc: Minivelle and Estradiol Transdermal Patches Recalled for Adhesive Failure

Agency Publication Date: April 20, 2021
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Summary

Noven Pharmaceuticals is recalling 22,932 cartons of Minivelle (estradiol) and generic Estradiol transdermal patches because the patches may not stick properly to the skin. This defect, caused by an out-of-specification release rate and adhesive shear, means the delivery system for the medication is compromised. If a patch does not remain securely attached, the patient may not receive the full intended dose of medication. These prescription hormone replacement therapies were distributed nationwide across the United States.

Risk

The patches are failing to meet quality standards for adhesive properties and medication release rates, which means they can peel off or fail to stick. This prevents the patient from receiving a consistent and accurate dose of estradiol, potentially leading to a recurrence of symptoms or ineffective treatment.

What You Should Do

  1. Check your medication packaging for Minivelle (estradiol transdermal system) 0.075 mg/day with NDC 68968-6675-8, specifically Lot 88584 with an expiration date of 03/2022.
  2. Check your medication packaging for generic Estradiol Transdermal System 0.0375 mg/day with NDC 68968-3437-8, specifically Lot 88321 with an expiration date of 02/2022.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you are using patches from these specific lots.
  4. Return any unused product from the affected lots to the pharmacy where you purchased it for a refund.
  5. Contact Noven Pharmaceuticals at their Miami headquarters or through their customer service channels if you have specific questions regarding this quality defect.
  6. For additional information or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Contact healthcare provider or pharmacist for guidance.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Minivelle (estradiol transdermal system) Delivers 0.075 mg/day (8 patches/box)
Model:
NDC 68968-6675-8
Recall #: D-0336-2021
Lot Numbers:
88584 (Exp. 03/2022)
Date Ranges: March 2022
Product: Estradiol Transdermal System Delivers 0.0375 mg/day (8 Systems/box)
Model:
NDC 68968-3437-8
Recall #: D-0337-2021
Lot Numbers:
88321 (Exp. 02/2022)
Date Ranges: February 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87741
Status: Resolved
Manufacturer: Noven Pharmaceuticals Inc
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2 products (12060 cartons; 10872 cartons)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.