FDA recall D-891-2013

Total Resources Intl · Class II · drug

Product

(No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET PREPARED,326 Pieces of Name Brand & Quality First Aid Supplies, FIRST AID, Total Resources International, Walnut, CA 91789

Reason for recall

CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2013-04-09
Report date
2013-08-21
Termination date
2014-01-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
City of Industry, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-891-2013