FDAClass IINovember 27, 2013

Oxcarbazepine Oral Suspension recall

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

Why was Oxcarbazepine Oral Suspension recalled?

Resuspension Problems: Recalled lot did not meet resuspendability requirements.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 161304B, Exp. OCT 2013

Product
Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC…
Recalling firm
Boehringer Ingelheim Roxane Inc
Quantity
10,267 bottles
Distribution
Nationwide
Recall date
November 27, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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