Reported Jul 23, 2014 · Terminated
Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage:…
Axcentria Pharmaceuticals, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Axcentria Pharmaceuticals, LLC · 306 Keystone Dr · Telford, PA · 18969
Is this the product you have?
- Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional
- Product Application or UsageProvides 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
- Lot codes and dates
lot # H13136exp. August 2014
- Amount recalled
- 528
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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