Reported Dec 3, 2014 · Terminated
Dharma Cavity Varnish 15mL
Dharma Research, Inc.
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: Dharma Research, Inc. · 5220 Nw 72nd Ave · Miami, FL · 33166-4860
Is this the product you have?
- Dharma Cavity Varnish 15mL
- Lot codes and dates
- All Lots - Item # 14-00016
- Amount recalled
- 916
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
During an FDA inspection it was found that the products are marketed without a cleared 510k.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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