Mitotane API Recalled for Potential Penicillin Cross-Contamination
Attix Pharmaceuticals is recalling Mitotane 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the potential for penicillin cross-contamination in a pharmaceutical context represents a significant health risk consistent with a Severe rating for a Class II drug recall.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Mitotane 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 total quantity involved is 21,500 grams.
The recall was initiated because the product was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates the potential for cross-contamination with penicillin. The affected product was distributed nationwide to compounding pharmacies and research organizations.
Compounding pharmacies and research organizations that received this product should stop using it and contact the recalling firm for instructions on return or disposal. Patients or consumers who have received medications compounded with this specific API should consult their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Mitotane 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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