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Terminated

SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.

FDA Recall Z-0004-2014 · Posted 2013-10-01

Recalling FirmASO, LLC
Recall StatusTerminated
Product CodeMXE
Date Initiated2013-08-21
Date Terminated2014-08-04
Product Quantity37 cases (72 retail boxes in each case)

Reason for Recall

No antibacterial bandages were packed in boxes labeled as antibacterial.

Firm Action

A letter was sent via e-mail and mail to the only customer on August 23, 2013 that a recall of two lots was in progress and to examine their inventory and stop distribution of the product. Product was to be either place in quarantine or destroyed. A credit for all returned product or by returned completed certificate of destruction.

Root Cause

Labeling Change Control

Distribution Pattern

Distributed in the states of ID, WI, IN, and NE.

Official Source

View FDA Recall →

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

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