Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0854-2008 · Posted 2008-02-19

Recalling FirmFirst Aid Only Inc
Recall StatusTerminated
Product CodeLRR
Date Initiated2007-12-10
Date Terminated2011-04-08
Product Quantity2,005 cabinets

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide: USA and to one distributor in Dubai, United Arab Emirates.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑