Axcentria Recalls Hemo-Stat Solution for Lack of FDA Approval
Axcentria Pharmaceuticals is recalling Hemo-Stat Solution because it was marketed without an approved NDA/ANDA and lacks an NDC number.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific issue is regulatory non-compliance (lack of approval/NDC) rather than a direct physical hazard like contamination or injury.
Plain-English summary
Axcentria Pharmaceuticals, LLC is recalling Hemo-Stat Solution, a 25% aluminum chloride solution in 37.2 g glass bottles. The product was distributed nationwide by Benco Dental, Henry Shein, and iSmile Dental Products. A total of 20,369 bottles are affected by this recall.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product was manufactured and distributed without a National Drug Code (NDC) number.
Dentists and dental offices should stop using the affected products and contact the recalling firm for instructions on how to return them.
The recalled product
- Product
- Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA
- Manufacturer
- Axcentria Pharmaceuticals, LLC
- Category
- Drug — Dental Hemostatic
- Affected units
- 20,369
Distribution
Distributed nationwide across the United States.
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