Drug 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
D-002-2014
Product summary
- Event
- Event 66289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,267 bottles
- Official record key
drug-enforcement:D-002-2014
Official wording
Reason: Resuspension Problems: Recalled lot did not meet resuspendability requirements.
Code information: Lot # 161304B, Exp. OCT 2013
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Resuspension Problems: Recalled lot did not meet resuspendability requirements.