Attix Pharmaceuticals Recalls Metaxalone API Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Metaxalone 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 risk in a pharmaceutical product, which aligns with the rubric for high-risk hazards without reported illness.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Metaxalone 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. This process creates a potential for cross-contamination with penicillin.
The affected product was distributed nationwide to compounding pharmacies and research organizations. There are no reports of illness or injury associated with this recall.
The recalled product
- Product
- Metaxalone 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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