Clobazam tablets recalled for contamination with foreign tablets
Amerisource Health Services LLC is recalling Clobazam 10 mg tablets nationwide due to contamination with foreign tablets or capsules. Patients should contact their pharmacist or healthcare provider.
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: This FDA Class II drug recall involves contamination with foreign tablets or capsules, classified as a risk-of-harm product. No illnesses or injuries are reported in the source material, meeting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Amerisource Health Services LLC is recalling Clobazam (clobazam tablets, 10 mg) distributed nationwide in the United States due to contamination. The recalled product consists of 30-tablet cartons packaged as 3x10 blister cards, with 4,640 units affected. The lot in question is #1018598 with an expiration date of 10/31/2025.
The recall was initiated because foreign tablets or capsules have been found in affected units. These foreign items pose a potential safety risk if ingested along with the intended medication.
Patients currently taking Clobazam should check the lot number and expiration date on their medication against this recall. Those with the affected product should not continue taking the medication and should contact their pharmacist or healthcare provider immediately for guidance on next steps.
This is an FDA Class II recall.
The recalled product
- Product
- CLOBAZAM (CLOBAZAM)
- Brand
- CLOBAZAM
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Affected units
- 4,640
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 #: 1018598
- Exp. Date 10/31/2025
Distribution
Distributed nationwide across the United States.
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