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.
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. 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 de
- 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
Related recalls
Same manufacturer · Axcentria Pharmaceuticals, LLC
See all →- ModerateAxcentria Recalls Hemo-Stat Solution for Lack of FDA Approval
FDA (Drugs) · 2014-07-23
- LowMajor Oral Peroxide Recalled Due to Stability Data Concerns
FDA (Drugs) · 2013-01-30
- LowAxcentria Recalls Infants' Mapap Due to Incorrect Expiration Date Labeling
FDA (Drugs) · 2012-08-08
Same hazard · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01