Recall of ICEE Peach Scented Antibacterial Hand Gel for CGMP Deviations
NingBo Huize Commodity Co., Ltd. is recalling ICEE Peach Scented Antibacterial Hand Gel because stability testing was not conducted on the product.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a CGMP deviation regarding stability testing, which is a documentation and process issue rather than a direct contamination or injury risk.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling ICEE Peach Scented Antibacterial Hand Gel (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC. The product is distributed by JFL Enterprises, Inc. in Cleveland, Ohio. The recall involves 13,068 units.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, stability testing was not conducted on the manufactured sunscreen and hand sanitizer OTC products. The affected lots are 20181130 (Exp 11/29/2020) and 20181203 (Exp 12/2/2020). The product was manufactured in China and distributed to seven consignees located in China.
No illnesses or injuries have been reported in connection with this recall. Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- ICEE PEACH SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
- Manufacturer
- NingBo Huize Commodity Co.,Ltd.
- Category
- Drug — OTC Hand Sanitizer
- Affected units
- 13,068
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 20181130
- Exp 11/29/2020
- 20181203
- Exp 12/2/2020
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 36 recalled by NingBo Huize Commodity Co.,Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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