Ibuprofen tablet refills in cardboard boxes or clear plastic bags for first aid kits and cabinets First Aid Only, Inc.,
FDA device recall Z-0855-2008 · 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
- GAA41
- Quantity affected
- 62,302 tablets
- 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
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