FDA Drug Moderate Class II Terminated

Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59

Reported: November 27, 2013 Initiated: April 3, 2013 #D-002-2014

Product Description

Reason for Recall

Resuspension Problems: Recalled lot did not meet resuspendability requirements.

Details

Recalling Firm: Boehringer Ingelheim Roxane Inc
Units Affected: 10,267 bottles
Distribution: Nationwide
Location: Columbus, OH

Frequently Asked Questions

What product was recalled? ▼

Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59. Recalled by Boehringer Ingelheim Roxane Inc. Units affected: 10,267 bottles.

Why was this product recalled? ▼

Resuspension Problems: Recalled lot did not meet resuspendability requirements.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on November 27, 2013. Severity: Moderate. Recall number: D-002-2014.