Recall Z-0854-2008 ยท LRR First Aid Kit With Drug
First Aid Only Inc
First Aid Only brand cabinets (typically metal wall mount) containing ibuprofen tablets and a variety of other first aid supplies: Item 249-0/FAO Item 249-0/P Item 249-RK/P First Aid Exchange brand cabinet: Item 1300-FAE-0103 Item 1300-FAE-0108 and Item 1300-PAT-0109
| Date | Feb 19, 2008 (initiated Dec 10, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 2,005 cabinets |
| Distribution | Worldwide: USA and to one distributor in Dubai, United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.