Irbesartan API Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Irbesartan 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 hazard where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Irbesartan active pharmaceutical ingredient (API) packaged in bags or drums. The recall covers all products repackaged and distributed between January 5, 2012, and February 12, 2015.
The recall is being conducted because the products were repackaged in a facility that also handled penicillin products without adequate separation. This process created the potential for cross-contamination with penicillin.
The affected product was distributed nationwide to compounding pharmacies and research organizations. No specific illnesses or injuries have been reported in the source text. Consumers and healthcare providers should stop using the affected lots and contact their supplier or the recalling firm for further instructions.
The recalled product
- Product
- Irbesartan 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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