Drug product
ICEE PEACH SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
D-1557-2019
Product summary
- Event
- Event 83018
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,068
- Official record key
drug-enforcement:D-1557-2019
Official wording
Reason: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Code information: Lot #: 20181130, Exp 11/29/2020; 20181203, Exp 12/2/2020
Distribution pattern: Foreign manufacturer located in China and distributed to seven consignees located in China.
Derived failure modes
-
Manufacturing or process control
CGMP deviations