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Terminated

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.

FDA Recall Z-2069-2014 · Posted 2014-07-16

Recalling FirmAxcentria Pharmaceuticals, LLC
Recall StatusTerminated
Product CodeEJK
Date Initiated2014-06-05
Date Terminated2016-11-28
Product Quantity528

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.

Firm Action

Axcentria Pharmaceuticals sent an urgent medical device recall notice, dated June 5, 2014, was sent to customers and described the product, problem, and actions to be taken. Customers were asked to fill out and return the form included. For questions customers were instructed to call 215-453-5055, ext 317.

Root Cause

No Marketing Application

Distribution Pattern

US distribution to NY and CA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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