Recalls / Class II
Class IID-002-2014
Product
Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59
- Affected lot / code info
- Lot # 161304B, Exp. OCT 2013
Why it was recalled
Resuspension Problems: Recalled lot did not meet resuspendability requirements.
Recalling firm
- Firm
- Boehringer Ingelheim Roxane Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 10,267 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-04-03
- FDA classified
- 2013-11-20
- Posted by FDA
- 2013-11-27
- Terminated
- 2014-02-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-002-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.