Drug product
Adventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0212
D-0247-2023
Product summary
- Event
- Event 91410
- Status
- Terminated
- Classification
- Class I
- Quantity
- 75381 packets
- Official record key
drug-enforcement:D-0247-2023
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 # W06H15, exp 08/15/2024
Distribution pattern: Nationwide and Canada.
Derived failure modes
-
Microbial contamination
Microbial Contamination