Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03

Class I - Dangerous
💊 Drugs Recalled: April 18, 2014 Apotex Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot # KM4951; Exp. 04/15
  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:
Apotex Corp.
Reason for Recall:
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03

Product Codes/Lot Numbers:

Lot # KM4951; Exp. 04/15

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1609-2014

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