Attix Pharmaceuticals Recalls Mitomycin C Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Mitomycin C active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant harm (penicillin cross-contamination) are categorized as Severe.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Mitomycin C active pharmaceutical ingredient 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 material 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 total quantity involved is 2,356 grams. The recall is classified as FDA Class II.
Compounding pharmacies and research organizations should stop using the affected Mitomycin C and contact Attix Pharmaceuticals for instructions on how to return or dispose of the product. Patients should consult their healthcare providers if they have received medication containing this ingredient.
The recalled product
- Product
- Mitomycin C 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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