NingBo Huize Recalls Strawberry Scented Antibacterial Hand Gel for CGMP Deviations
NingBo Huize Commodity Co., Ltd. is recalling 13,068 units of Air Heads Strawberry 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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/process deviation (lack of stability testing) rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling 13,068 units of Air Heads Strawberry Scented Antibacterial Hand Gel (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC. The product is distributed by JFL Enterprises, Inc. in Cleveland, Ohio. The recall involves two lots: Lot #20181116 (Exp 11/15/2020) and Lot #20181119 (Exp 11/18/2020).
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 product was manufactured in China and distributed to seven consignees located in China.
Consumers who have this product should stop using it and contact the recalling firm for further instructions. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- AIR HEADS STRAWBERRY 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 #: 20181116
- Exp 11/15/2020
- 20181119
- Exp 11/18/2020
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.
See all 36 products in this recall →Related recalls
Same manufacturer · NingBo Huize Commodity Co.,Ltd.
See all →- LowNingBo Huize Recalls SPF 30 Sunscreen Lotion Due to Missing Stability Testing
FDA (Drugs) · 2019-08-07
- LowNingBo Huize Recalls Dippin' Dots Hand Gel Due to Missing Stability Testing
FDA (Drugs) · 2019-08-07
- LowNingBo Huize Recalls Air Heads Hand Gel for Missing Stability Testing
FDA (Drugs) · 2019-08-07
- LowHand Gel Recalled for Missing Stability Testing
FDA (Drugs) · 2019-08-07
- LowFestpak Sunscreen Recalled for Missing Stability Testing
FDA (Drugs) · 2019-08-07
Same hazard · cgmp deviation
See all →- SevereZicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures
FDA (Drugs) · 2026-09-02
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- SevereShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- ModerateShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- HighShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19