FDA Recall
Terminated
SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
Recall: Z-0004-2014
·
Initiated August 21, 2013
Recall
- Recall Number
- Z-0004-2014
- Event Number
- 66357
- Firm
- ASO, LLC
- FEI Number
- 1038758
- Product Code
- MXE
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- August 21, 2013
- Posted
- October 1, 2013
- Terminated
- August 4, 2014
- Address
- 300 Sarasota Center Blvd, Sarasota, FL, 34240-9381
Description
SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
Reason
No antibacterial bandages were packed in boxes labeled as antibacterial.
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.
Distribution
Distributed in the states of ID, WI, IN, and NE.
Quantity
37 cases (72 retail boxes in each case)