Recall Z-0475-2015 ยท LBH Varnish, Cavity
Dharma Research, Inc.
Dharma Cavity Varnish with Fluoride
| Date | Dec 1, 2014 (initiated Sep 29, 2014) |
| Status | Terminated |
| Reason | During an FDA inspection, it was found that the products are being marketed without a cleared 510k. |
| Root cause | No Marketing Application |
| Action | On September 29, 2014 the firm sent a notification to its consignees informing them of the product being discountued and removed. The firm asked for the product to be returned directly to Dharma's office at 5220 NW 72 Avenue, Suite 15, Miami FL 33166. For any questions please do not hesitate to call (305) 482-9669. |
| Quantity | 2,842 |
| Distribution | Worldwide Distribution: US Distribution in states of: CA, PA, FL, IL, including Puerto Rico; and countries of: Honduras, Dominican Republic, Turkey, Nicaragua, Colombia, Pakistan, Trinidad & Tobago, Guatemala, Phillipines, Saudi Arabia, and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.