Medications & Supplements/Prescription Drugs

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

Agency Publication Date: October 18, 2018

Summary

Amerigen Pharmaceuticals Inc. has recalled 5,232 bottles of Temozolomide capsules (20 mg), a prescription chemotherapy medication, because the drug failed to dissolve properly during stability testing. When a medication does not dissolve correctly, the body may not absorb the active ingredient at the intended rate, which can potentially impact the effectiveness of the treatment. This recall affects both 5-count and 14-count bottles distributed nationwide in the United States.

Risk

If the capsules do not dissolve according to specifications, patients may receive a dose that is less effective than prescribed for their condition. No specific injuries or adverse health consequences have been reported to date for this low-risk (Class III) recall.

What You Should Do

Identify your medication by checking the bottle for Temozolomide capsules, 20 mg, and look for NDC codes 43975-253-05 (5-count bottle) or 43975-253-14 (14-count bottle).
Check the bottle label for Lot # 17F058A (for 5-count bottles) or Lot # 17F058B (for 14-count bottles), both with an expiration date of June 2019 (Exp 6/19).
Immediately contact your healthcare provider or pharmacist for guidance on your treatment if you find you have an affected bottle.
Return any unused product to the pharmacy where it was purchased for a refund and further instructions.
Contact Amerigen Pharmaceuticals Inc. at their distributor location in Lyndhurst, NJ, or your pharmacist for more information regarding this voluntary recall.
For additional questions or to report a problem, 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 provider consultation and pharmacy 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, 20 mg (5-count bottle)

Model:

NDC 43975-253-05

Lot Numbers:

17F058A (Exp 6/19)

Date Ranges: Exp 6/19

Product: Temozolomide capsules, 20 mg (14-count bottle)

Model:

NDC 43975-253-14

Lot Numbers:

17F058B (Exp 6/19)

Date Ranges: Exp 6/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81189

Status: Resolved

Manufacturer: Amerigen Pharmaceuticals Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 5,232 bottles: a) 4,146 bottles; b) 1,086 bottles

Distributed To: Nationwide

Agency Last Updated: November 15, 2018

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

Identify your medication by checking the bottle for Temozolomide capsules, 20 mg, and look for NDC codes 43975-253-05 (5-count bottle) or 43975-253-14 (14-count bottle).

Check the bottle label for Lot # 17F058A (for 5-count bottles) or Lot # 17F058B (for 14-count bottles), both with an expiration date of June 2019 (Exp 6/19).

Immediately contact your healthcare provider or pharmacist for guidance on your treatment if you find you have an affected bottle.

Return any unused product to the pharmacy where it was purchased for a refund and further instructions.

Contact Amerigen Pharmaceuticals Inc. at their distributor location in Lyndhurst, NJ, or your pharmacist for more information regarding this voluntary recall.

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