Finasteride API Recalled for Potential Penicillin Cross-Contamination
Attix Pharmaceuticals is recalling finasteride 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 risks or hospitalization reports are rated Severe (4). While no injuries are explicitly reported, the potential for penicillin cross-contamination in a drug product represents a significant health risk consistent with this classification.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of finasteride active pharmaceutical ingredient (API) 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 was initiated because the finasteride API was repackaged in a facility that also handled penicillin products without adequate separation. This process created a 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. Compounding pharmacies and research organizations should stop using the affected lots and contact the recalling firm for instructions.
The recalled product
- Product
- Finasteride 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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