Attix Pharmaceuticals Recalls Estrone API Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Estrone active pharmaceutical ingredient because it was repackaged in a facility with penicillin products without adequate separation, creating a cross-contamination risk.
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 involving significant injury risks or hospitalization reports are rated as Severe (4). 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 this classification.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Estrone 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 Estrone was repackaged in a facility that also handled penicillin products without adequate separation between the products.
The FDA has classified this recall as Class II. The lack of adequate separation during repackaging creates a potential for cross-contamination with penicillin. Penicillin is a known allergen, and exposure could pose a risk to individuals with penicillin allergies.
The affected Estrone API was distributed nationwide to compounding pharmacies and research organizations. Compounding pharmacies and research organizations should stop using the affected product and contact Attix Pharmaceuticals for further instructions. Consumers who have compounded medications containing this specific API should consult their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Estrone 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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