Attix Pharmaceuticals Recalls Lidocaine HCl Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Lidocaine HCl active pharmaceutical ingredient due to potential penicillin cross-contamination from inadequate facility separation.
What this means for you
Illness, injury, or structural failure has been reported. 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 involving significant injury reports or high-risk scenarios are rated Severe (4). While no specific injuries are reported in the text, the potential for penicillin cross-contamination in a pharmaceutical context represents a significant health risk warranting a Severe classification under the Class II criteria.
Plain-English summary
Attix Pharmaceuticals is recalling Lidocaine HCl active pharmaceutical ingredient (API) packaged in bags or drums. The recall covers all lots repackaged and distributed between January 5, 2012, and February 12, 2015. The product was distributed nationwide to compounding pharmacies and research organizations.
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 total quantity involved is 33,300 grams.
Compounding pharmacies and research organizations that received this product should stop using it and contact the recalling firm for instructions. Consumers should not use this product if they have it in their possession.
The recalled product
- Product
- Lidocaine 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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