Attix Pharmaceuticals Recalls Pentosan Polysulfate Sodium Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Pentosan Polysulfate Sodium active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant harm (such as penicillin cross-contamination in a pharmaceutical context) align with a Severe rating, particularly given the risk of severe allergic reactions in sensitive individuals.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Pentosan Polysulfate Sodium 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 in the recall is 36,955 grams.
The recall was initiated because the 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.
Compounding pharmacies and research organizations that received this product should stop using it and contact Attix Pharmaceuticals for instructions on how to return or dispose of the material. Consumers who have compounded medications containing this ingredient should consult their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Pentosan Polysulfate Sodium 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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