Z-2069-2014Class II

Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application...

Name: Z-2069-2014 Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application...
Creator: Axcentria Pharmaceuticals, LLC
Published: 2014-06-05
License: https://open.fda.gov/license/

Axcentria Pharmaceuticals, LLC / initiated 2014-06-05 / Terminated / root cause: labeling and UDI

FDA source

Axcentria Pharmaceuticals, LLC began a recall of Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious... on 2014-06-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2069-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-05
Posted: 2014-07-16
Terminated: 2016-11-28
Recalling firm: Axcentria Pharmaceuticals, LLC
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.
Product code: EJK Liner, Cavity, Calcium Hydroxide
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.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
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.
Quantity in commerce: 528
Distribution: US distribution to NY and CA
Product codes and lots: lot # H13136, exp. August 2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2069-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2069-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-16

Product code EJK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)