Recall Z-0855-2008
First Aid Only Inc · initiated December 10, 2007
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
Codes / lots: Lot Code: HA09707 (exp. 12/09)
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: Nonconforming Material/Component
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.
Details
- Recall number
- Z-0855-2008
- Initiated
- December 10, 2007
- Posted by FDA
- February 19, 2008
- Terminated
- April 8, 2011
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Quantity
- 62,302 tablets
- Distribution
- Worldwide: USA and to one distributor in Dubai, United Arab Emirates.
- Recalling firm
- First Aid Only Inc, Vancouver, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0853-2008 | First Aid Kits, soft canvas, plastic, and metal containers holding various products to…Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits… | 12/10/2007Terminated |
| Z-0854-2008 | First Aid Only brand cabinets (typically metal wall mount) containing ibuprofen tablets…Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits… | 12/10/2007Terminated |