The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1558-2019·Announced 2019-08-07

ICEE Cherry Scented Antibacterial Hand Gel Recalled for Missing Stability Testing

NingBo Huize Commodity Co., Ltd. is recalling ICEE Cherry 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 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 13,068 units of ICEE Cherry 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 units include Lot # 20181204 (Expiration 12/3/2020) and Lot # 20181205 (Expiration 12/4/2020).

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. Consumers should stop using the product and contact the distributor for further instructions.

The recalled product

Product
ICEE CHERRY 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 #: 20181204
  • Exp 12/3/2020
  • 20181205
  • Exp 12/4/2020

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.

See all 36 products in this recall →

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