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
Reported: June 2, 2021 Initiated: March 15, 2021 #D-0570-2021
Product Description
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.
Details
- Recalling Firm
- Cardinal Health Inc.
- Units Affected
- 490 bottles
- Distribution
- FL, GA, SC
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cardinal Health Inc.. Units affected: 490 bottles.
Why was this product recalled? ▼
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0570-2021.
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