Recalls / Class III
Class IIID-1609-2014
Product
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
- Affected lot / code info
- Lot # KM4951; Exp. 04/15
Why it was recalled
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, N/A, Weston, Florida 33326-3253
Distribution
- Quantity
- 5,397 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-04-18
- FDA classified
- 2014-09-24
- Posted by FDA
- 2014-10-01
- Terminated
- 2017-04-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1609-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.