Attix Pharmaceuticals Recalls Cisplatin Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling cisplatin active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk scenarios are rated as Severe (4).
Plain-English summary
Attix Pharmaceuticals is recalling all lots of cisplatin active pharmaceutical ingredient 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 recall is being conducted because the material was repackaged in a facility that also handled penicillin products without adequate separation, creating a potential for cross-contamination.
The recalled product was distributed nationwide to compounding pharmacies and research organizations. The FDA has classified this recall as Class II, indicating a situation in which there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare professionals who have this product should contact their healthcare provider or the recalling firm for instructions on how to proceed. Do not use the product until further notice.
The recalled product
- Product
- Cisplatin 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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