Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: a) 18J043A, Exp 09/30/2020, b) 18J043B, Exp 09/30/2020
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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
- 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, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
Product Codes/Lot Numbers:
Lot #: a) 18J043A, Exp 09/30/2020, b) 18J043B, Exp 09/30/2020
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0516-2019
Related Recalls
Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14
Amerigen Pharmaceuticals
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.