Drug product
Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%), 0.9 g (0.03 oz) packets packaged in boxes of 10, Treatment for Burns, Made in China for Adventure Ready Brands, 944 Industrial Park Rd., Littleton, NH 03561, NDC 90107-0210, Product # 9999-1515
D-0244-2023
Product summary
- Event
- Event 91410
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2880 packets
- Official record key
drug-enforcement:D-0244-2023
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 # W06I28, exp 09/28/2024
Distribution pattern: Nationwide and Canada.
Derived failure modes
-
Microbial contamination
Microbial Contamination