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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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Low RiskFDA Drug
Medications & Supplements/Topical Products

InvaGen Pharmaceuticals, Inc.: Testosterone Topical Solution Recalled for Defective Pump and Incorrect Dosing

Agency Publication Date: August 2, 2019
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Summary

InvaGen Pharmaceuticals has recalled 1,776 bottles of Testosterone Topical Solution (30mg per pump) due to a defect in the container's actuator pump. This mechanical failure can cause the pump to function improperly, preventing the delivery of the correct prescribed dose of medication. The affected products were manufactured by Cipla Ltd and distributed nationwide in 110 mL bottles designed to deliver 90 mL of solution. If you use this medication, check your bottle for lot numbers GH80480 or GH80481 with an expiration date of March 2020.

Risk

A malfunctioning actuator pump may deliver an inconsistent or incorrect amount of testosterone to the patient. This could lead to under-dosing or over-dosing, which may negatively impact the effectiveness of the treatment or cause unintended side effects related to hormone levels.

What You Should Do

  1. Check your medication bottle to see if it is Testosterone Topical Solution 30mg per pump actuation (NDC 69097-363-44).
  2. Verify the lot information on the packaging; the affected products are Lot GH80480 and Lot GH80481 with an expiration date of 3/2020.
  3. If your bottle matches the affected lots, contact your healthcare provider or pharmacist immediately for guidance on how to continue your treatment safely.
  4. Return any unused or defective product to your pharmacy for a refund and to ensure the manufacturer is notified of the failure.
  5. Contact InvaGen Pharmaceuticals or the distributor at 11722-4415 for further instructions regarding the return or replacement process.
  6. For additional questions or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall return 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: Testosterone Topical Solution 30mg of testosterone per pump actuation (110 mL)
Model:
NDC 69097-363-44
Recall #: D-1454-2019
Lot Numbers:
GH80480 (exp 3/2020)
GH80481 (exp 3/2020)
Date Ranges: Expiration 3/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83117
Status: Resolved
Manufacturer: InvaGen Pharmaceuticals, Inc.
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 1776 bottles
Distributed To: Nationwide

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 ยท 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.