Dharma Cavity Varnish with Fluoride
FDA device recall Z-0475-2015 · posted 2014-12-01 · Terminated
Recall details
- Recalling firm
- Dharma Research, Inc.
- Reason for recall
- During an FDA inspection, it was found that the products are being marketed without a cleared 510k.
- 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.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- LBH
- Quantity affected
- 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, G
- Date initiated
- 2014-09-29
- Date posted
- 2014-12-01
- Date terminated
- 2016-10-03
- Location
- Miami, FL
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