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
Product summary
- 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
CGMP Deviations