NingBo Huize Recalls Dots Scented Antibacterial Hand Gel for CGMP Deviations
NingBo Huize Commodity Co., Ltd. is recalling Dots 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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/testing deviation (stability testing not conducted) rather than a direct physical hazard.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling 3,852 units of Dots Scented Antibacterial Hand Gel Strawberry (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL. The product was manufactured in China and distributed to seven consignees located in China. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically that stability testing was not conducted on the manufactured sunscreen and hand sanitizer OTC products.
The recalled product is identified by Lot # 20181023 and has an expiration date of 10/22/2020. The product is distributed by JFL Enterprises, Inc. in Cleveland, Ohio. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who have this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the product. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- DOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (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
- 3,852
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 (2)
- Lot #: 20181023
- Exp 10/22/2020
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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