Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.

Class I - Dangerous
💊 Drugs Recalled: December 20, 2016 Mylan Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    LOT #: a) 2006895 and 2006896, Exp 02/18; b) 2006895, Exp 02/18
  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:
Mylan LLC.
Reason for Recall:
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
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, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.

Product Codes/Lot Numbers:

LOT #: a) 2006895 and 2006896, Exp 02/18; b) 2006895, Exp 02/18

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0441-2017

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