Attix Pharmaceuticals Recalls Trifluridine API Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Trifluridine active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
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 agency classification is FDA Class II, and the hazard involves potential penicillin cross-contamination, which poses a significant risk of severe allergic reactions (anaphylaxis) in sensitive individuals, fitting the 'Severe' criteria for significant injury risk.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Trifluridine active pharmaceutical ingredient (API) that were repackaged and distributed between January 5, 2012, and February 12, 2015. The product is packaged in varying grams or kilograms in bags or drums. The recall is being conducted because the API was repackaged in a facility that also handled penicillin products without adequate separation, creating a potential for cross-contamination with penicillin.
The affected product was distributed nationwide to compounding pharmacies and research organizations. The specific quantity mentioned in the structured data is 68 grams, though the recall covers all lots distributed during the specified period. No specific illnesses or injuries have been reported in the source text.
Consumers and healthcare professionals who possess this product should stop using it and contact the recalling firm or their healthcare provider for instructions on return or disposal. Compounding pharmacies and research organizations should verify their inventory against the distribution dates and product details provided.
The recalled product
- Product
- Trifluridine 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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