Attix Pharmaceuticals Recalls Felbamate Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Felbamate active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
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 involves a high-risk allergen (penicillin) cross-contamination risk in a pharmaceutical product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Felbamate active pharmaceutical ingredient (API) packaged in bags or drums. The recall covers products repackaged and distributed between January 5, 2012, and February 12, 2015.
The recall was initiated because the products were repackaged in a facility that also handled penicillin products without adequate separation. This condition creates a potential for cross-contamination with penicillin.
The affected product was distributed nationwide to compounding pharmacies and research organizations. No specific illness or injury reports are mentioned in the source text.
The recalled product
- Product
- Felbamate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
- Manufacturer
- Attix Pharmaceuticals
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)
- All lots repackaged and distributed between 01/05/12 to 02/12/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 470 recalled by Attix Pharmaceuticals 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.
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