Tootsie Roll Antibacterial Hand Gel Recalled for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll POP Orange Scented Antibacterial Hand Gel because stability testing was not conducted.
What this means for you
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 (missing stability testing) without reported illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll POP Orange 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 5,112 units with Lot # 20181015 and an expiration date of 10/14/2020.
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
- Tootsie Roll POP ORANGE 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
- 5,112
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 #: 20181015
- Exp 10/14/2020
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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