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Terminated

Dharma Cavity Varnish 15mL

FDA Recall Z-0476-2015 · Posted 2014-12-01

Recalling FirmDharma Research, Inc.
Recall StatusTerminated
Product CodeLBH
Date Initiated2014-09-29
Date Terminated2016-10-03
Product Quantity916

Reason for Recall

During an FDA inspection it was found that the products are marketed without a cleared 510k.

Firm 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.

Root Cause

No Marketing Application

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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