The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-002-2014·Announced 2013-11-27

Boehringer Ingelheim Recalls Oxcarbazepine Oral Suspension Due to Resuspension Issues

Boehringer Ingelheim is recalling 10,267 bottles of Oxcarbazepine Oral Suspension because the product failed to meet resuspendability requirements.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a quality defect (resuspendability) rather than a high-risk pathogen or structural defect, fitting the criteria for a moderate severity score.

Plain-English summary

Boehringer Ingelheim Roxane Inc. is recalling 10,267 bottles of Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottles. The affected product is identified by Lot # 161304B with an expiration date of OCT 2013. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall was initiated because the recalled lot did not meet resuspendability requirements. This means the medication may not mix properly when shaken, which could affect the consistency of the dose. The product was distributed nationwide.

Consumers who have this specific lot of Oxcarbazepine Oral Suspension should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment. The recall number is D-002-2014.

The recalled product

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
Manufacturer
Boehringer Ingelheim Roxane Inc
Category
Drug — Anticonvulsant
Hazard
Affected units
10,267

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 161304B
  • Exp. OCT 2013

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Boehringer Ingelheim Roxane Inc

See all →

Same hazard · quality defect

See all →

Similar recalls