Attix Pharmaceuticals Recalls Pimecrolimus Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Pimecrolimus 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 classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury potential or hospitalization reports are Severe. While no injuries are explicitly reported, the risk of penicillin cross-contamination in a pharmaceutical ingredient is a significant safety hazard warranting a Severe rating under the Class II criteria.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Pimecrolimus 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 API 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. No specific illness or injury reports are mentioned in the source text.
The recalled product
- Product
- Pimecrolimus 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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