Drug product
Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2129
D-0248-2023
Product summary
- Event
- Event 91410
- Status
- Terminated
- Classification
- Class I
- Quantity
- 37464 packets
- Official record key
drug-enforcement:D-0248-2023
Official wording
Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Code information: Lot # W05L28, exp 12/28/2023
Distribution pattern: Nationwide and Canada.
Derived failure modes
-
Microbial contamination
Microbial Contamination