Tootsie Roll Hand Gel Recalled for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll Fruit Chews Vanilla 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 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 confirmed safety hazard.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling 8,856 units of Tootsie Roll Fruit Chews Vanilla 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 lot number is 20181113, with an expiration date of 11/12/2020.
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
- TOOTSIE ROLL FRUIT CHEWS VANILLA 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
- 8,856
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 #: 20181113
- Exp 11/12/2020
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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