Attix Pharmaceuticals Recalls Estradiol Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Estradiol active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk allergen (penicillin) cross-contamination risk where no illnesses have been reported, which aligns with the rubric criteria for a High severity score.
Plain-English summary
Attix Pharmaceuticals is recalling Estradiol active pharmaceutical ingredient (API) packaged in bags or drums. The recall covers all lots of all products that were repackaged and distributed between January 5, 2012, and February 12, 2015. The affected product was distributed nationwide to compounding pharmacies and research organizations.
The recall was initiated because the products were repackaged in a facility that also handled penicillin products without adequate separation. This condition creates a potential for cross-contamination with penicillin. The source text does not report any specific illnesses or injuries associated with this recall.
Compounding pharmacies and research organizations that received these products should stop using them and contact the recalling firm for instructions on return or disposal. Consumers should not use any Estradiol products derived from these specific lots if they have been dispensed to them.
The recalled product
- Product
- Estradiol 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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