Z-0855-2008

Ibuprofen tablet refills in cardboard boxes or clear plastic bags for first aid kits and cabinets First Aid...

Name: Z-0855-2008 Ibuprofen tablet refills in cardboard boxes or clear plastic bags for first aid kits and cabinets First Aid...
Creator: First Aid Only Inc
Published: 2007-12-10
License: https://open.fda.gov/license/

Acme United Corp. / initiated 2007-12-10 / Terminated / root cause: manufacturing process

FDA source

First Aid Only Inc began a recall of 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... on 2007-12-10. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0855-2008
Status: Terminated
Initiated: 2007-12-10
Posted: 2008-02-19
Terminated: 2011-04-08
Recalling firm: Acme United Corp.
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
Product code: GAA41
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 62,302 tablets
Distribution: Worldwide: USA and to one distributor in Dubai, United Arab Emirates.
Product codes and lots: Lot Code: HA09707 (exp. 12/09)

Product code GAA41

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)