Tootsie Roll Hand Gel Recalled for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll Fruit Chews Lime Scented Antibacterial Hand Gel because stability testing was not conducted.
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 agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a documentation/testing deviation (missing stability testing) rather than a confirmed contamination or defect.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling 8,856 units of Tootsie Roll Fruit Chews Lime 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 20181114, with an expiration date of 11/13/2020.
The product was manufactured by a foreign facility in China and distributed to seven consignees located in China. Consumers should check their inventory for this specific lot and expiration date.
The recalled product
- Product
- TOOTSIE ROLL FRUIT CHEWS LIME 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 #: 20181114
- Exp 11/13/2020
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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