Supernus Recalls Trokendi XR Capsules Due to Assay Failure
Supernus Pharmaceuticals is recalling Trokendi XR (topiramate) capsules because they failed to meet assay specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which is reasonably likely to cause temporary or medically reversible adverse health consequences. The hazard is a failure of assay specifications, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Supernus Pharmaceuticals, Inc. is recalling Trokendi XR (topiramate) extended-release capsules, 50mg, 30-count blister packs. The recall affects 17,128 units distributed nationwide. The specific lot number is 426636, with an expiration date of 4/22/18.
The recall was initiated because the capsules failed to meet assay specifications. This indicates that the amount of active ingredient in the capsules may not be within the required limits.
Consumers and healthcare providers should stop using the affected Trokendi XR capsules and contact their healthcare provider for guidance on alternative treatment options. The product is a prescription-only medication.
The recalled product
- Product
- TROKENDI XR (TOPIRAMATE)
- Brand
- TROKENDI XR
- Manufacturer
- Supernus Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
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 (2)
- Lot # 426636
- Exp 4/22/18
UPCs (4)
- 0317772101300
- 0317772102307
- 0317772104301
- 0317772103304
Distribution
Distributed nationwide across the United States.
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