The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1555-2019·Announced 2019-08-07

NingBo Huize Recalls Air Heads Hand Gel for Missing Stability Testing

NingBo Huize Commodity Co., Ltd. is recalling Air Heads Orange Scented Antibacterial Hand Gel because stability testing was not conducted on the product.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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 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 mislabeling.

Plain-English summary

NingBo Huize Commodity Co., Ltd. is recalling 13,068 units of Air Heads Orange 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 20181126 (Exp 11/25/2020) and 20181127 (Exp 11/26/2020).

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 ORANGE 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
Hazard
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 #: 20181126
  • Exp 11/25/2020
  • 20181127
  • Exp 11/26/2020

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 →

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