Attix Pharmaceuticals Recalls Furosemide Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling furosemide active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
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 in a pharmaceutical product, which fits the rubric for 'High' severity due to the risk of harm without reported illness.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of furosemide active pharmaceutical ingredient (API) that were repackaged and distributed between January 5, 2012, and February 12, 2015. The product was 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 furosemide API was distributed nationwide to compounding pharmacies and research organizations. The recall covers all lots of all products repackaged and distributed during the specified timeframe. There is no indication in the source text that specific illnesses or injuries have been reported as a result of this contamination.
Compounding pharmacies and research organizations that received this product should stop using it and contact Attix Pharmaceuticals for further instructions. Consumers should not use furosemide products derived from this API if they have been advised by their healthcare provider to do so.
The recalled product
- Product
- Furosemide 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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