Status
Terminated
Drug Enforcement D-0244-2023
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Classification
Class I
Report Date
February 8, 2023
Termination Date
July 29, 2025
Product Information
- Product description
- 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
- Product quantity
- 2880 packets
- Reason for recall
- Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide and Canada.
Location & Firm
- Recalling firm
- GFA Production Xiamen Co. Ltd.
- Address
-
Huli Industrial Park No. 20, Meixi Road; Tong'An
China - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0244-2023
- Event ID
- 91410
- Recall initiation date
- December 23, 2022
- Center classification date
- January 27, 2023
- Code info
- Lot # W06I28, exp 09/28/2024
- More code info
- —