FDA recall D-0624-2018
United Pacific Co Ltd · Class II · drug
Product
Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
Reason for recall
CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
Distribution
Nationwide within US
Key facts
- Status
- Terminated
- Initiation date
- 2018-03-29
- Report date
- 2018-04-18
- Termination date
- 2019-01-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- South El Monte, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0624-2018