Reported Nov 27, 2013 · Terminated
Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc.…
Boehringer Ingelheim Roxane Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boehringer Ingelheim Roxane Inc · 1809 Wilson Rd · Columbus, OH · 43228-9579
Is this the product you have?
- Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59
- Lot codes and dates
Lot # 161304BExp. OCT 2013
- Amount recalled
- 10,267 bottles
Where it was sold
- Nationwide
Why it was recalled
Resuspension Problems: Recalled lot did not meet resuspendability requirements.
This product could cause temporary or reversible health problems — stop using it.
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