Drug 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
D-1529-2019
Product summary
- Event
- Event 83018
- Status
- Terminated
- Classification
- Class III
- Quantity
- 35,500
- Official record key
drug-enforcement:D-1529-2019
Official wording
Reason: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Code information: Lot #: 20170619, Exp 6/18/2019; 20170620, Exp 6/19/2019; 20170621, Exp 6/20/2019
Distribution pattern: Foreign manufacturer located in China and distributed to seven consignees located in China.
Derived failure modes
-
Manufacturing or process control
CGMP deviations