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Terminated

Amerigel Wound Dressing 1 oz. tube

FDA Recall Z-1992-2014 · Posted 2014-07-04

Recalling FirmKova Laboratories, Inc.
Recall StatusTerminated
Product CodeMGQ
Date Initiated2014-03-21
Date Terminated2016-09-12
Product Quantity122,396 / 1oz. tubes

Reason for Recall

Product may not have been manufactured pursuant to a validated process protocol and CGMP.

Firm Action

Kova Laboratories contacted customers with an URGENT: Medical Device Recall message by phone and e-mail 3/21/2014 and 4/21/2014, of the affected products to be returned.

Root Cause

Process control

Distribution Pattern

Distributed in the states of FL and NJ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971918AMERIGEL OINTMENT SATURATED WOUND DRESSINGAmerx Health Care Corp. · 1997-08-12

Official Source

View FDA Recall →

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

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