Drug product
Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
D-0624-2018
Product summary
- Event
- Event 79693
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,190 boxes
- Official record key
drug-enforcement:D-0624-2018
Official wording
Reason: CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
Code information: Lot #:14122921, Exp.12/30/20119, 15091512, Exp. 9/15/2020, 6032321, Exp. 3/23/2021, 17030921, Exp. 3/09/2022
Distribution pattern: Nationwide within US
Derived failure modes
-
Manufacturing or process control
CGMP Deviations