Drug product
Good to Go Hand Sanitizer (Ethyl Alcohol 62%), 1 FL OZ (30 mL), OTC, Made in China for Cashco Distributors Inc. 6430 N. E. Columbia Blvd Portland OR 97218
D-1530-2019
Product summary
- Event
- Event 83018
- Status
- Terminated
- Classification
- Class III
- Quantity
- 52,160
- Official record key
drug-enforcement:D-1530-2019
Official wording
Reason: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Code information: Lot #: 20180601 Exp 5/31/2020, 20180604 Exp 6/3/2020, 20180820 Exp 8/19/2020, 20180821 Exp 8/20/2020, 20180822 Exp 8/21/2020
Distribution pattern: Foreign manufacturer located in China and distributed to seven consignees located in China.
Derived failure modes
-
Manufacturing or process control
CGMP deviations