Baclofen API Recalled for Potential Penicillin Cross-Contamination
Attix Pharmaceuticals is recalling Baclofen 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 recall is classified as FDA Class II, and the hazard involves potential cross-contamination with penicillin, a known allergen that can cause severe reactions, meeting the criteria for a Severe rating.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Baclofen active pharmaceutical ingredient (API) 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 total quantity involved in the recall is 134,535 grams.
The recall was initiated because the Baclofen API was repackaged in a facility that also handled penicillin products without adequate separation. This condition created the potential for cross-contamination with penicillin. The affected product was distributed nationwide to compounding pharmacies and research organizations.
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 this product, as it is an active pharmaceutical ingredient intended for professional use in compounding or research, not for direct consumer consumption.
The recalled product
- Product
- Baclofen 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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