Air Heads Antibacterial Hand Gel Recalled for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling Air Heads Blue Raspberry Scented 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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issue is a documentation/testing deviation rather than a direct safety hazard.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling 13,068 units of Air Heads 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 20181120 (Exp 11/19/2020) and 20181121 (Exp 11/20/2020).
The product was manufactured in China and distributed to seven consignees located in China. 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
- AIR HEADS 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 #: 20181120
- Exp 11/19/2020
- 20181121
- Exp 11/20/2020
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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