Attix Pharmaceuticals Recalls Leucovorin Calcium Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Leucovorin Calcium 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 agency classified this as an FDA Class II recall. Per the rubric, an FDA Class II recall involving a significant hazard (penicillin cross-contamination) is categorized as Severe.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Leucovorin Calcium 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 involves 9,611 grams of the ingredient.
The recall was initiated 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 affected product was distributed nationwide to compounding pharmacies and research organizations.
The U.S. Food and Drug Administration has classified this recall as Class II. Compounding pharmacies and research organizations that received this product should stop using it and follow the instructions provided by the recalling firm.
The recalled product
- Product
- Leucovorin Calcium 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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