Status
Terminated
Drug Enforcement D-002-2014
Resuspension Problems: Recalled lot did not meet resuspendability requirements.
Classification
Class II
Report Date
November 27, 2013
Termination Date
February 11, 2014
Product Information
- Product description
- Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59
- Product quantity
- 10,267 bottles
- Reason for recall
- Resuspension Problems: Recalled lot did not meet resuspendability requirements.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- Address
-
1809 Wilson Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-002-2014
- Event ID
- 66289
- Recall initiation date
- April 3, 2013
- Center classification date
- November 20, 2013
- Code info
- Lot # 161304B, Exp. OCT 2013
- More code info
- —