Calcium Hydroxide Powder — Class II medical device recall Z-2069-2014
Terminated recall by Axcentria Pharmaceuticals, LLC, reported 2014-07-23, distributed in CA, NY. One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an a
| Recall number | Z-2069-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Axcentria Pharmaceuticals, LLC, Telford, PA, United States |
| Recall initiated | 2014-06-05 |
| Classified | 2014-07-16 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2016-11-28 |
| Distributed | CA, NY |
| Quantity | 528 |
| Reason classes | labeling, unapproved product |
| Lot numbers | H13136 |
| Expiration dates | 2014-08-20 |
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 decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration.
Reason for recall
One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2069-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.