Hand Gel Recalled for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling DIPPIN' DOTS Scented Banana Split Antibacterial Hand Gel because stability testing was not conducted.
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 unlikely to cause adverse health consequences. The issue is a documentation and testing deviation (missing stability testing) rather than a confirmed safety hazard.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling 13,068 units of DIPPIN' DOTS Scented Banana Split Antibacterial Hand Gel (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 recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, stability testing was not conducted on the manufactured hand sanitizer OTC products. The affected lot number is 20181210, with an expiration date of 12/09/2020.
The product was manufactured in China and distributed to seven consignees located in China. Consumers should stop using the product and contact the distributor for further instructions.
The recalled product
- Product
- DIPPIN' DOTS SCENTED BANANA SPLIT 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
- Hazard
- 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 (2)
- Lot #: 20181210
- Exp 12/09/2020
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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