Attix Pharmaceuticals Recalls Nitazoxanide Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Nitazoxanide 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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the risk of severe allergic reactions from penicillin cross-contamination.
Plain-English summary
Attix Pharmaceuticals is recalling Nitazoxanide active pharmaceutical ingredient (API) packaged in bags or drums. The recall covers all lots repackaged and distributed between January 5, 2012, and February 12, 2015. The product was distributed nationwide to compounding pharmacies and research organizations.
The recall was initiated because the product was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates a potential for cross-contamination with penicillin. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Compounding pharmacies and research organizations that received this product should stop using it and contact Attix Pharmaceuticals for instructions on return or disposal. Patients or consumers who have received medications containing this specific API from a compounding pharmacy should consult their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Nitazoxanide 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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