Attix Pharmaceuticals Recalls Mepivacaine HCl Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Mepivacaine HCl active pharmaceutical ingredient due to potential penicillin cross-contamination during repackaging.
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 source text identifies the hazard as penicillin cross-contamination, which poses a significant risk of severe allergic reactions or anaphylaxis. Per the rubric, significant injury reports or high-risk contamination scenarios align with a Severe (4) rating.
Plain-English summary
Attix Pharmaceuticals is recalling Mepivacaine HCl active pharmaceutical ingredient (API) packaged in bags or drums. The recall covers all lots of all products that were 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 products were repackaged in a facility that also handled penicillin products without adequate separation. This condition creates a potential for cross-contamination with penicillin. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Compounding pharmacies and research organizations that received this product should stop using it and contact Attix Pharmaceuticals for further instructions. Consumers should not use this active pharmaceutical ingredient, as it is intended for professional use in the preparation of final drug products.
The recalled product
- Product
- Mepivacaine 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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