DOTS Scented Antibacterial Hand Gel Recalled for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling DOTS Scented Antibacterial Hand Gel Lime 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 indicates the product is not likely to cause adverse health consequences. The issue is a documentation and testing deviation (missing stability testing) rather than a direct safety hazard like contamination or injury.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling DOTS Scented Antibacterial Hand Gel Lime (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC. The product was distributed by JFL Enterprises, Inc. in Cleveland, Ohio. The recall involves 3,852 units with Lot # 20181022 and an expiration date of 10/21/2020.
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 or injuries associated with this recall.
The product was manufactured in China and distributed to seven consignees located in China. Consumers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the point of purchase or disposed of according to local regulations.
The recalled product
- Product
- DOTS SCENTED ANTIBACTERIAL HAND GEL LIME (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 #: 20181022
- Exp 10/21/2020
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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