Axcentria Recalls Calcium Hydroxide Powder Due to Missing 510(k) Approval
Axcentria Pharmaceuticals is recalling one lot of Calcium Hydroxide Powder because it was distributed without FDA approval and lacks usage instructions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The hazard involves regulatory non-compliance (missing 510(k)) and labeling deficiencies (missing instructions) rather than a direct physical defect or reported illness, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Axcentria Pharmaceuticals, LLC is recalling one lot of Calcium Hydroxide Powder, USP. The product is intended for use by health care professionals in root canal therapy to provide a bactericidal effect and protect the vital pulp.
The recall was initiated because the product was manufactured and distributed without an approved 510(k) submission. Additionally, the current label does not include instructions for use. The affected lot is identified as # H13136 with an expiration date of August 2014.
The recall involves 528 units that were distributed to New York and California. Health care professionals who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further…
- Manufacturer
- Axcentria Pharmaceuticals, LLC
- Category
- Medical Device — Dental
- Affected units
- 528
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 (2)
- lot # H13136
- exp. August 2014.
Distribution
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