Medications & Supplements/Prescription Drugs

Paddock Laboratories, LLC.: Evamist (estradiol transdermal spray) Recalled for Defective Delivery System

Agency Publication Date: March 28, 2018

Summary

Paddock Laboratories, LLC. is recalling 52,596 bottles of Evamist (estradiol transdermal spray), 1.53mg/spray, because the glass vials may have cracks in the neck near the metal crimp. This defect can cause the medication to evaporate or leak, which may result in you receiving an incorrect dose or being unable to dispense the product at all. This recall affects specific bottles distributed nationwide across the United States.

Risk

Cracks in the vial neck can lead to product evaporation or leakage, preventing the delivery of the correct amount of medication. This could result in ineffective treatment for symptoms related to the prescription's intended use.

What You Should Do

Check your medication bottle for Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, in a 0.27 fl oz (8.1 mL) bottle with NDC 0574-2067-27.
Look for Lot number MEEF with an expiration date of 04/2020 on the packaging to determine if your product is part of the recall.
If you have an affected bottle, contact your healthcare provider or pharmacist for guidance on continuing your treatment and obtaining a replacement.
Return any unused product from the affected lot to the pharmacy where you purchased it for a refund.
Contact the manufacturer, Paddock Laboratories, LLC., for further instructions regarding this recall.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and refund

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

Affected Products

Product: Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL)

Model:

NDC: 0574-2067-27

Recall #: D-0608-2018

Lot Numbers:

MEEF (Exp. 04/2020)

Date Ranges: Expiration 04/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79334

Status: Resolved

Manufacturer: Paddock Laboratories, LLC.

Sold By: pharmacies; healthcare providers

Manufactured In: United States

Units Affected: 52,596 bottles

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.

Summary

What You Should Do

Check your medication bottle for Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, in a 0.27 fl oz (8.1 mL) bottle with NDC 0574-2067-27.

Look for Lot number MEEF with an expiration date of 04/2020 on the packaging to determine if your product is part of the recall.

If you have an affected bottle, contact your healthcare provider or pharmacist for guidance on continuing your treatment and obtaining a replacement.

Return any unused product from the affected lot to the pharmacy where you purchased it for a refund.

Contact the manufacturer, Paddock Laboratories, LLC., for further instructions regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.