Supernus Pharmaceuticals, Inc. — Class III: Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufact
Supernus Pharmaceuticals, Inc. has initiated a Class III recall for Trokendi XR (topiramate) 50 mg extended-release capsules due to failure to meet dissolution specifications. The affected product was manufactured by Catalent Pharma Solutions and the recall status is currently listed as ongoing.
This recall affects Supernus Pharmaceuticals, Inc., its contract manufacturer Catalent Pharma Solutions, and professionals involved in the quality control and distribution of topiramate extended-release products.
A Class III recall indicates that the product's failure to meet dissolution specifications is unlikely to cause adverse health consequences, but still represents a violation of FDA standards. For regulatory and quality professionals, this suggests potential issues in the manufacturing process or stability profile of the extended-release formulation at the Winchester, KY facility. It underscores the importance of stringent oversight of contract manufacturing organizations (CMOs) to ensure adherence to finished product specifications.
Quality teams should review dissolution testing protocols for extended-release formulations and evaluate batch retention samples for similar stability trends. Verify that contract manufacturing agreements include clear reporting requirements for specification failures detected during stability or release testing.
Class III. Reason: Failed dissolution specifications.. Product: Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.. Firm: Supernus Pharmaceuticals, Inc. (Rockville MD United States). Status: Ongoing.
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