NingBo Huize Recalls ICEE Blue Raspberry Hand Gel for Stability Testing Failures
NingBo Huize Commodity Co., Ltd. is recalling ICEE Blue Raspberry 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 as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling 13,068 units of ICEE Blue Raspberry Scented 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 sunscreen and hand sanitizer OTC products. The affected lots are 20181206 (Exp 12/5/2020) and 20181207 (Exp 12/6/2020). The product was manufactured in China and distributed to seven consignees located in China.
The U.S. Food and Drug Administration (FDA) has classified this recall as Class III. This classification indicates that the product is not likely to cause adverse health consequences or death. Consumers should stop using the product and follow instructions from the recalling firm or distributor.
The recalled product
- Product
- ICEE BLUE RASPBERRY 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
- 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 (4)
- Lot #: 20181206
- Exp 12/5/2020
- 20181207
- Exp 12/6/2020
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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