Attix Pharmaceuticals Recalls D-Penicillamine Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling D-Penicillamine active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
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 ingredient, which poses a significant risk of severe allergic reactions, but no specific illnesses or injuries are reported in the source text.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of D-Penicillamine active pharmaceutical ingredient (API) packaged in bags or drums. The product was distributed nationwide to compounding pharmacies and research organizations between January 5, 2012, and February 12, 2015.
The recall was initiated because the D-Penicillamine was repackaged in a facility that also handled penicillin products. The FDA determined that inadequate separation between the products created a potential for cross-contamination with penicillin.
Compounding pharmacies and research organizations that received this product should stop using it and contact the recalling firm for instructions on return or disposal. Consumers should not use D-Penicillamine API directly, as it is an ingredient intended for professional pharmaceutical compounding.
The recalled product
- Product
- D-Penicillamine 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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