NingBo Huize Recalls CHARMS Antibacterial Hand Gel for CGMP Deviations
NingBo Huize Commodity Co., Ltd. is recalling CHARMS Blow Pop Scented Antibacterial Hand Gel because stability testing was not conducted on the OTC products.
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 CHARMS Blow Pop Sour Apple Scented Antibacterial Hand Gel (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC. The product was distributed by JFL Enterprises, Inc. in Cleveland, Ohio. The recall involves 18,036 units.
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 20181102 (Exp 11/1/2020) and 20181105 (Exp 11/4/2020). The product was manufactured in China and distributed to seven consignees located in China.
Consumers who have this product should stop using it and follow instructions from the recalling firm or the FDA. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- CHARMS BLOW POP SOUR APPLE 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
- 18,036
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 #: 20181102
- Exp 11/1/2020
- 20181105
- Exp 11/4/2020
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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