Hand Sanitizer Recalled for Missing Stability Testing
NingBo Huize Commodity Co., Ltd. is recalling 50,000 units of 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 indicates the product is unlikely to cause adverse health consequences. The issue is a documentation and testing deviation rather than a direct safety hazard.
Plain-English summary
NingBo Huize Commodity Co., Ltd. is recalling 50,000 units of Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC. The product was manufactured in China and distributed to seven consignees located 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 20180410, 20180411, 20180830, and 20180831.
The U.S. Food and Drug Administration has classified this as a Class III recall. Consumers should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Texas Home Health Home Care Hospice 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
- 50,000
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 (8)
- Lot #: 20180410
- Exp 4/9/2020
- 20180411
- Exp 4/10/2020
- 20180830
- Exp 8/29/2020
- 20180831
- Exp 8/30/2020
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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