Oxcarbazepine Oral Suspension Recalled Due to Manufacturing and Stability Deviations
Akorn Inc. is recalling all lots of Oxcarbazepine Oral Suspension 300 mg/5 mL due to manufacturing practice deviations. The firm went out of business and could not complete required stability studies.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving CGMP deviations and incomplete stability studies. While no illnesses or injuries have been reported, the inability to verify medication stability represents a potential risk to product quality and efficacy.
Plain-English summary
Akorn Inc. is recalling all lots of Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL in 250 mL bottles. The recall affects product distributed nationwide in the United States and Puerto Rico. Oxcarbazepine is an oral medication used for seizure control.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the recalling firm went out of business and could no longer complete the stability studies required under FDA regulations. These studies are essential to verify that the medication maintains its quality and potency throughout its labeled shelf life.
The recall includes all lots distributed across all National Drug Codes (NDCs) for this product formulation.
The recalled product
- Product
- Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Hazard
- cgmp-deviation
- stability-concern
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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