Why it was recalled
Subpotent drug
Product description
Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
Lot numbers, UPCs & expiration codes
Lot # KL0664, Exp 04/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1081-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 7, 2015
- FDA report date
- May 20, 2015
- Quantity
- 5,352 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-1081-2015, exactly as published.
Show all FDA fields
- City
- Toronto
- Status
- Terminated
- Country
- Canada
- Event ID
- 71046
- Address
- 150 Signet Drive
- Code information
- Lot # KL0664, Exp 04/15
- Report date
- May 20, 2015
- Product type
- Drugs
- Recall number
- D-1081-2015
- Classification
- Class III
- Recalling firm
- Apotex Inc.
- Product quantity
- 5,352 bottles
- Termination date
- Apr 7, 2017
- Reason for recall
- Subpotent drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 7, 2015
- Initial firm notification
- Letter
- Center classification date
- May 14, 2015