Cardinal Health Recalls Trokendi XR Capsules Due to Temperature Excursions
Cardinal Health Inc. is recalling 490 bottles of Trokendi XR (topiramate) 100 mg capsules due to intermittent exposure to temperature excursions during storage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential adverse health consequences from CGMP deviations like temperature excursions.
Plain-English summary
Cardinal Health Inc. is recalling 490 bottles of Trokendi XR (topiramate) extended-release capsules, 100 mg, 30-count bottles. The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage, which constitutes a deviation from Current Good Manufacturing Practices (CGMP).
The affected product is identified by NDC 17772-103-30 and code 1741214. The capsules were manufactured by Catalent Pharma Solutions in Winchester, KY, for Supernus Pharmaceuticals, Inc. in Rockville, MD. The recall is classified as FDA Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The product was distributed to Florida, Georgia, and South Carolina. Consumers and healthcare providers should check their inventory for the specific NDC and code listed above. If the product is found, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this medication.
The recalled product
- Product
- TROKENDI XR (TOPIRAMATE)
- Brand
- TROKENDI XR
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 490
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)
- 1741214
UPCs (4)
- 0317772101300
- 0317772102307
- 0317772104301
- 0317772103304
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 198 products in this recall →Related recalls
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