Drug product
Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China
D-1534-2019
Product summary
- Event
- Event 83018
- Status
- Terminated
- Classification
- Class III
- Quantity
- 50,000
- Official record key
drug-enforcement:D-1534-2019
Official wording
Reason: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Code information: Lot #: 20180410, Exp 4/9/2020; 20180411, Exp 4/10/2020; 20180830, Exp 8/29/2020; 20180831, Exp 8/30/2020
Distribution pattern: Foreign manufacturer located in China and distributed to seven consignees located in China.
Derived failure modes
-
Manufacturing or process control
CGMP deviations