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U.S. Department of Health and Human Services

Class 3 Device Recall First Aid Only

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  Class 3 Device Recall First Aid Only see related information
Date Initiated by Firm December 10, 2007
Date Posted February 19, 2008
Recall Status1 Terminated 3 on April 08, 2011
Recall Number Z-0855-2008
Recall Event ID 46198
Product Classification Tablet refills-Ibuprofen - Product Code GAA41
Product Ibuprofen tablet refills in cardboard boxes or clear plastic bags for first aid kits and cabinets First Aid Only, Inc., Vancouver, WA.
Ibuprofen Tablets, Item A405-WIP, Item A405-10
Ibuprofen Tablets, Item FAE-7014;;
Ibuprofen Tablets, Item H430;
Ibuprofen Tablets, Item I431;
Ibuprofen Tablets, item J432 and
Ibuprofen Tablets, item Z6100
Code Information Lot Code: HA09707 (exp. 12/09)
Recalling Firm/
Manufacturer		 First Aid Only Inc
11101 Ne 37th Cir
Vancouver WA 98682-7218
For Additional Information Contact Bryan P. Kelley
360-254-9291
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 62,302 tablets
Distribution Worldwide: USA and to one distributor in Dubai, United Arab Emirates.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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