🔍 RecallPedia

Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.

Class I - Dangerous
💊 Drugs Recalled: October 5, 2018 Amerigen Pharmaceuticals Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: a) 17F058A, Exp 6/19; b) 17F058B, Exp 6/19
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Amerigen Pharmaceuticals Inc.
Reason for Recall:
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.

Product Codes/Lot Numbers:

Lot #: a) 17F058A, Exp 6/19; b) 17F058B, Exp 6/19

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0249-2019

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