Drug product
3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 91789
D-889-2013
Product summary
- Event
- Event 64929
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-889-2013
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: Lot 11215-05,11216-05, 11216-06, 11217-05
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations