Drug product
Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0213
D-0246-2023
Product summary
- Event
- Event 91410
- Status
- Terminated
- Classification
- Class I
- Quantity
- 60048 packets
- Official record key
drug-enforcement:D-0246-2023
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 #: W06C05, exp 03/05/2024; W06F10, exp 06/10/2024; W06H15, exp 08/15/2024.
Distribution pattern: Nationwide and Canada.
Derived failure modes
-
Microbial contamination
Microbial Contamination