Attix Pharmaceuticals Recalls Procarbazine HCl Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Procarbazine HCl active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
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 in a pharmaceutical product, which fits the rubric for high-risk hazards where injury has not yet been reported.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Procarbazine HCl 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 total quantity involved is 5,115 grams.
The recall is being conducted because the product was repackaged in a facility that also handled penicillin products without adequate separation. This condition creates a potential for cross-contamination with penicillin. The 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 that received this product should stop using it and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Procarbazine HCl 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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