Attix Pharmaceuticals Recalls Amoxicillin Trihydrate Due to Missing Stability Data
Attix Pharmaceuticals is recalling Amoxicillin Trihydrate active pharmaceutical ingredient because stability data does not support the printed expiry dates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is theoretical (lack of stability data), which aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Amoxicillin Trihydrate active pharmaceutical ingredient (API) that were repackaged and distributed between January 5, 2012, and February 12, 2015. The product is packaged in varying grams or kilograms in bags or drums. The recall is being conducted because the API was repackaged without data to support the printed expiry date.
The affected product was distributed nationwide to compounding pharmacies and research organizations. The recall covers all lots of all products repackaged and distributed within the specified timeframe. The agency has classified this recall as Class II.
Compounding pharmacies and research organizations that received this product should stop using it and contact the recalling firm for further instructions. Consumers should not use this active pharmaceutical ingredient directly, as it is intended for professional use in compounding or research settings.
The recalled product
- Product
- Amoxicillin Trihydrate 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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