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Recall Observatory FDA recall evidence

Drug product

(No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET PREPARED,326 Pieces of Name Brand & Quality First Aid Supplies, FIRST AID, Total Resources International, Walnut, CA 91789

D-891-2013

April 09, 2013

Class II

Product summary

Firm
Total Resources Intl
Event
Event 64929
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-891-2013

Official wording

Reason: CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.

Code information: Item Number 20-HBC-01015CCREV1.

Distribution pattern: Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations