Attix Pharmaceuticals Recalls Ticarcillin Sodium/Potassium Clavulanate API Due to Stability Data Issues
Attix Pharmaceuticals is recalling Ticarcillin Sodium/Potassium Clavulanate API because stability data does not support the printed expiry dates for lots distributed between 2012 and 2015.
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 explicitly states the issue is a lack of stability data supporting expiry dates without any reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Ticarcillin Sodium/Potassium Clavulanate (30:1) 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 was initiated because the repackaged products lack the necessary stability data to support the printed expiry dates. This means the manufacturer cannot verify that the product remains stable and effective until the dates printed on the packaging.
The affected product was distributed nationwide to compounding pharmacies and research organizations. There are no reports of illness or injury associated with this recall. Compounding pharmacies and research organizations should stop using the affected product and contact Attix Pharmaceuticals for further instructions.
The recalled product
- Product
- Ticarcillin Sodium/Potassium Clavulanate (30:1) 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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