Attix Pharmaceuticals Recalls Theophylline Anhydrous Due to Penicillin Cross-Contamination Risk
Attix Pharmaceuticals is recalling Theophylline Anhydrous 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. According to the rubric, FDA Class II recalls involving significant injury risks or hospitalization reports are rated as Severe (4). Penicillin cross-contamination poses a significant risk of severe allergic reactions.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Theophylline Anhydrous active pharmaceutical ingredient. The product is packaged in varying grams or kilograms in bags or drums. The recall covers all lots repackaged and distributed between January 5, 2012, and February 12, 2015.
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.
Compounding pharmacies and research organizations should stop using the affected product and contact Attix Pharmaceuticals for further instructions. Consumers should not use this active pharmaceutical ingredient, as it is intended for professional use in compounding or research settings.
The recalled product
- Product
- Theophylline Anhydrous 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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