FDAFDA · Food and drugs·Recall number D-0570-2021
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
Published June 2, 2021 · Recall initiated: March 15, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TROKENDI XR
- Manufacturer
- Cardinal Health Inc.
- Distributor
- FL, GA, SC
- UPC
- 0317772101300
- Lot
- 1741214
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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