Recalls / Class III
Class IIID-1564-2019
Product
Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China.
- Affected lot / code info
- Lot #: 20170410, Exp 04/09/2019; 20170515, Exp 05/14/2019; 20170516, Exp 05/15/2019; 20170517, Exp 05/16/2019; 20170518, Exp 05/17/2019; 20170519, Exp 05/18/2019; 20170522, Exp 05/21/2019; 20170523, Exp 05/22/2019: 20170524, Exp 05/23/2019; 20170525, Exp 05/24/2019; 20170526, Exp 05/25/2019; 20180615, Exp 06/14/2020
Why it was recalled
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recalling firm
- Firm
- NingBo Huize Commodity Co.,Ltd.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14 Lizhou Road, N/A, Yuyao, N/A N/A, China
Distribution
- Quantity
- 126,500
- Distribution pattern
- Foreign manufacturer located in China and distributed to seven consignees located in China.
Timeline
- Recall initiated
- 2019-04-01
- FDA classified
- 2019-07-27
- Posted by FDA
- 2019-08-07
- Terminated
- 2023-06-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1564-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.