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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: February 20, 2019
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Summary

Amerigen Pharmaceuticals Inc. is recalling approximately 5,768 bottles of Temozolomide (5 mg) capsules, a prescription chemotherapy medication, because the product failed dissolution specifications. This defect means the capsules may not break down correctly in the body, which could prevent a patient from receiving the full dose of their medication. The recall affects 5-count and 14-count bottles distributed to wholesalers and retailers across the United States. Consumers should contact their healthcare provider or pharmacist immediately to discuss their treatment options.

Risk

When a drug fails dissolution specifications, the medication may not be properly absorbed by the body. This can lead to a lower-than-intended dose of the chemotherapy, which may reduce the effectiveness of the treatment for the patient.

What You Should Do

  1. Check your medication packaging for Temozolomide Capsules, 5 mg, with NDC numbers 43975-252-05 (5-count bottle) or 43975-252-14 (14-count bottle).
  2. Verify if your bottle belongs to lot number 18J043A or 18J043B, both of which have an expiration date of 09/30/2020.
  3. If you identify an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on your treatment and how to obtain a replacement.
  4. Return any unused product from the affected lots to your pharmacy to receive a refund and ensure the medication is disposed of properly.
  5. Contact Amerigen Pharmaceuticals at their Lyndhurst, NJ office (9 Polito Ave Ste 900, Lyndhurst, NJ 07071) for additional information regarding this recall.
  6. For further questions or to report an adverse event, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare guidance and product refund

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

Affected Products

Product: Temozolomide Capsules, 5 mg (5-count bottle)
Model:
NDC 43975-252-05
Lot Numbers:
18J043A (Exp 09/30/2020)
Date Ranges: 09/30/2020
Product: Temozolomide Capsules, 5 mg (14-count bottle)
Model:
NDC 43975-252-14
Lot Numbers:
18J043B (Exp 09/30/2020)
Date Ranges: 09/30/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82158
Status: Resolved
Manufacturer: Amerigen Pharmaceuticals Inc.
Sold By: wholesalers; distributors; retail accounts
Manufactured In: United States
Units Affected: a) 2,413 bottles b) 3,355 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.