NingBo Huize Recalls Air Heads Hand Gel for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling Air Heads Pink Lemonade 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 indicates the product is unlikely 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 13,068 units of Air Heads Pink Lemonade 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 20181122 (Exp 11/21/2020) and 20181123 (Exp 11/22/2020).
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
- AIR HEADS PINK LEMONADE 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 #: 20181122
- Exp 11/21/2020
- 20181123
- Exp 11/22/2020
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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