Tootsie Roll Grape Hand Gel Recalled for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll POP Grape 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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a documentation/process issue (missing stability testing) with no reported illnesses.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling Tootsie Roll POP Grape 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, and manufactured in China.
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 source text does not report any illnesses or injuries associated with this recall.
The recall involves 5,112 units with Lot # 20181018 and an expiration date of 10/17/2020. The distribution pattern indicates the foreign manufacturer is located in China and the product was distributed to seven consignees located in China. Consumers should check their inventory for this specific lot number and stop using the product if found.
The recalled product
- Product
- Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed By: JFL Enterprises, Inc. Cleveland, Ohio 44102, Made in China
- Manufacturer
- NingBo Huize Commodity Co.,Ltd.
- Category
- Drug — OTC Hand Sanitizer
- 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 #: 20181018
- Exp 10/17/2020
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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