NingBo Huize Recalls ICEE Hand Gel for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling ICEE Lemon Lime Scented Antibacterial Hand Gel because stability testing was not conducted on the product.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences. The issue is a documentation/testing deviation rather than a direct safety hazard.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling 13,068 units of ICEE Lemon Lime Scented Antibacterial Hand Gel (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL. The product was distributed by JFL Enterprises, Inc. in Cleveland, Ohio, to seven consignees located in China.
The recall was initiated 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 20181128 (Exp 11/27/2020) and 20181129 (Exp 11/28/2020).
The U.S. Food and Drug Administration has classified this recall as Class III. Consumers should stop using the product and contact the distributor for further instructions.
The recalled product
- Product
- ICEE LEMON LIME 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 #: 20181128
- Exp 11/27/2020
- 20181129
- Exp 11/28/2020
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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