🔍 RecallPedia

Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01

Class I - Dangerous
💊 Drugs Recalled: September 15, 2014 Astellas Pharma US Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot 66482CW, Exp 04/16
  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:
Astellas Pharma US Inc
Reason for Recall:
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine 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:

Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01

Product Codes/Lot Numbers:

Lot 66482CW, Exp 04/16

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0008-2015

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