Recall Z-0476-2015
Dharma Research, Inc. · initiated September 29, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dharma Cavity Varnish 15mL
Codes / lots: All Lots - Item # 14-00016
Reason for recall
During an FDA inspection it was found that the products are marketed without a cleared 510k.
FDA-determined cause: No Marketing Application
Action taken
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.
Details
- Recall number
- Z-0476-2015
- Initiated
- September 29, 2014
- Posted by FDA
- December 1, 2014
- Terminated
- October 3, 2016
- Product code
- LBH – Varnish, Cavity
- Quantity
- 916
- 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.
- Recalling firm
- Dharma Research, Inc., Miami, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0475-2015 Class II | Dharma Cavity Varnish with FluorideDuring an FDA inspection, it was found that the products are being marketed without a cleared 510k. | 09/29/2014Terminated |