The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1536-2019·Announced 2019-08-07

Tootsie Roll Antibacterial Hand Gel Recalled for Missing Stability Testing

NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll POP Chocolate Scented Antibacterial Hand Gel because stability testing was not conducted.

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 Tootsie Roll POP Chocolate 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 5,112 units with Lot # 20181016 and an expiration date of 10/15/2020.

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 by a foreign facility in China and distributed to seven consignees located in China.

Consumers who have this product should stop using it and contact the distributor or manufacturer for further instructions. 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
Tootsie Roll POP CHOCOLATE 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
5,112

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 (2)

  • Lot #: 20181016
  • Exp 10/15/2020

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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