DOTS Scented Antibacterial Hand Gel Recalled for Stability Testing Deviations
NingBo Huize Commodity Co., Ltd. is recalling DOTS Scented Antibacterial Hand Gel Orange 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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a documentation/process deviation (lack of stability testing) with no reported injuries.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling 3,852 units of DOTS Scented Antibacterial Hand Gel Orange (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL. The product is an over-the-counter (OTC) item distributed by JFL Enterprises, Inc. in Cleveland, Ohio. The specific lot number is 20181019, with an expiration date of 10/18/2020.
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 source text does not report any illnesses, injuries, or adverse health consequences associated with this recall.
The product was manufactured in China and distributed to seven consignees located in China. Consumers who possess this specific lot of hand gel should stop using it and follow instructions from the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- DOTS SCENTED ANTIBACTERIAL HAND GEL ORANGE (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 #: 20181019
- Exp 10/18/2020
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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