First Aid Kits, soft canvas, plastic, and metal containers holding various products to include ibuprofen and other first

FDA device recall Z-0853-2008 · posted 2008-02-19 · Terminated

Recall details

Recalling firm

First Aid Only Inc

Reason for recall

Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits, tablet refills, and cabinets, is being recalled for failing its USP limits for impurities during stability testing.

Action taken

The firm issued an Urgent Device Recall letter dated 10/10/07 to consignees receiving any of the products. The letter instructs consignees to return any recalled product to the firm. If any recalled prdoucts were further distributed, the consignee was requested to notify those consignees and have product returned.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LRR

Quantity affected

72,904 kits

Distribution

Worldwide: USA and to one distributor in Dubai, United Arab Emirates.

Date initiated

2007-12-10

Date posted

2008-02-19

Date terminated

2011-04-08

Location

Vancouver, WA