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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/Prescription Drugs

Amerigen Pharmaceuticals Inc.: Temozolomide Capsules Recalled for Failed Dissolution Specifications

Agency Publication Date: December 26, 2018
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Summary

Amerigen Pharmaceuticals Inc. is recalling approximately 4,323 bottles of Temozolomide (20 mg and 180 mg), a prescription medication used in chemotherapy. The recall was issued because the capsules failed dissolution testing, meaning the medication may not dissolve and release into the body at the required rate. This defect could potentially make the treatment less effective than intended. Consumers should check their prescription bottles to see if they have the affected lot numbers.

Risk

The failure to meet dissolution specifications means the medication may not be absorbed properly by the body. This could result in a patient receiving an incorrect dose of their chemotherapy treatment, potentially impacting the management of their medical condition.

What You Should Do

  1. Check your medication bottle for Temozolomide Capsules, 20 mg, with NDC numbers 43975-253-05 (5-count bottle) or 43975-253-14 (14-count bottle). Look for lot numbers 18B005 A or 18B005 B with an expiration date of 02/2020.
  2. Check your medication bottle for Temozolomide Capsules, 180 mg, with NDC number 43975-256-14 (14-count bottle). Look for lot number 18E031 with an expiration date of 05/2020.
  3. Contact your healthcare provider or pharmacist immediately for guidance on your treatment if you find you have an affected bottle.
  4. Return any unused portions of the recalled medication to the pharmacy where you purchased it for a refund.
  5. Contact Amerigen Pharmaceuticals Inc. at 9 Polito Ave Ste 900, Lyndhurst, New Jersey, 07071-3410 for further instructions regarding this recall.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall baseline remedy

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

Affected Products

Product: Temozolomide Capsules, 20 mg (5-count bottle)
Model:
NDC 43975-253-05
Lot Numbers:
18B005 A (Exp 02/2020)
Date Ranges: 02/2020
Product: Temozolomide Capsules, 20 mg (14-count bottle)
Model:
NDC 43975-253-14
Lot Numbers:
18B005 B (Exp 02/2020)
Date Ranges: 02/2020
Product: Temozolomide Capsules, 180 mg (14-count bottle)
Model:
NDC 43975-256-14
Lot Numbers:
18E031 (Exp 05/2020)
Date Ranges: 05/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81858
Status: Resolved
Manufacturer: Amerigen Pharmaceuticals Inc.
Sold By: wholesalers; retail accounts
Manufactured In: United States
Units Affected: 2 products (3552 bottles; 771 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.