Home / Recalls / Kova Laboratories, Inc. / Z-1992-2014

Z-1992-2014 Class II Terminated

Recalled by Kova Laboratories, Inc. — Margate, FL

Recall Details

Product Type: Devices
Report Date: July 16, 2014
Initiation Date: March 21, 2014
Termination Date: September 12, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 122,396 / 1oz. tubes

Product Description

Amerigel Wound Dressing 1 oz. tube

Reason for Recall

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

Distribution Pattern

Distributed in the states of FL and NJ.

Code Information

Lot #3WD02, Lot #3WD03, Lot #3WD04 and Lot #3WD05.