Attix Pharmaceuticals Recalls Hyaluronic Acid Sodium Salt Injection Grade API
Attix Pharmaceuticals is recalling Hyaluronic Acid Sodium Salt (Injection Grade) 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 involves potential cross-contamination with penicillin, a high-risk allergen, which poses a significant risk of severe allergic reactions or anaphylaxis.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Hyaluronic Acid Sodium Salt (Injection Grade) active pharmaceutical ingredient (API) packaged in bags or drums. The product was repackaged and distributed between January 5, 2012, and February 12, 2015. The recall is being conducted because the product was repackaged in a facility that also handled penicillin products without adequate separation, creating a potential for cross-contamination with penicillin.
The affected product was distributed nationwide to compounding pharmacies and research organizations. The total quantity involved in the recall is 1,685 grams. The recall is classified as Class II by the U.S. Food and Drug Administration.
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 product if they have it in their possession.
The recalled product
- Product
- Hyaluronic Acid Sodium Salt (Injection Grade) 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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