Recalls / Class III
Class IIID-1534-2019
Product
Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China
- Affected lot / code info
- Lot #: 20180410, Exp 4/9/2020; 20180411, Exp 4/10/2020; 20180830, Exp 8/29/2020; 20180831, Exp 8/30/2020
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
- 50,000
- 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-1534-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.