Drug recall D-0570-2021

Class II Terminated reported Jun 2, 2021

Product

Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, NDC 17772-103-30

Reason for recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Lots and codes

1741214

Recall details

Recalling firm
Cardinal Health Inc., Dublin, OH
Quantity
490 bottles
Distribution
FL, GA, SC
Type
Voluntary: Firm initiated
Recall initiated
March 15, 2021
Terminated
June 17, 2024

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