Recalls / Class III
Class IIID-1081-2015
Product
Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
- Affected lot / code info
- Lot # KL0664, Exp 04/15
Why it was recalled
Subpotent drug
Recalling firm
- Firm
- Apotex Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Drive, N/A, Toronto, N/A N/A, Canada
Distribution
- Quantity
- 5,352 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-04-07
- FDA classified
- 2015-05-14
- Posted by FDA
- 2015-05-20
- Terminated
- 2017-04-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1081-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.