Why it was recalled
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Product 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
Lot numbers, UPCs & expiration codes
Lot # KM4951; 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-1609-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 18, 2014
- FDA report date
- Oct 1, 2014
- Quantity
- 5,397 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-1609-2014, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 69177
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Lot # KM4951; Exp. 04/15
- Postal code
- 33326-3253
- Report date
- Oct 1, 2014
- Product type
- Drugs
- Recall number
- D-1609-2014
- Classification
- Class III
- Recalling firm
- Apotex Corp.
- Product quantity
- 5,397 bottles
- Termination date
- Apr 7, 2017
- Reason for recall
- Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide.
- Recall initiation date
- Apr 18, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 24, 2014