NingBo Huize Recalls Hand Sanitizer for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling 35,500 units of Accent Care hand sanitizer 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 FDA classified this as a Class III recall, which the rubric defines as typically low severity (1 or 2) because it is unlikely to cause adverse health consequences. The issue is a documentation/testing deviation rather than a direct safety hazard like contamination.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling 35,500 units of Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL. The product is an over-the-counter (OTC) item manufactured in China.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, stability testing was not conducted on the manufactured hand sanitizer products. The affected lots are 20170619 (Exp 6/18/2019), 20170620 (Exp 6/19/2019), and 20170621 (Exp 6/20/2019).
The product was 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 manufacturer for instructions on return or disposal.
The recalled product
- Product
- Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China
- Manufacturer
- NingBo Huize Commodity Co.,Ltd.
- Category
- Drug — OTC Hand Sanitizer
- Affected units
- 35,500
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 (6)
- Lot #: 20170619
- Exp 6/18/2019
- 20170620
- Exp 6/19/2019
- 20170621
- Exp 6/20/2019
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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