Recalls / Class III
Class IIID-1079-2015
Product
Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
- Affected lot / code info
- Lot #: a) KL0655, Exp 04/15; KY2374, Exp 05/16; b) KL0656, Exp 04/15; KY2371, Exp 05/16
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
- 23,274 bottles/ blister cartons
- 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-1079-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.