D-0624-2018 Class II Terminated
FDA drug recall D-0624-2018 was initiated by United Pacific Co Ltd on March 29, 2018 and is designated Class II. Reason for recall: CGMP Deviations: the product was produced with substandard GMP manufacturing processes. The recall status is terminated (terminated January 24, 2019). Affected quantity: 15,190 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- April 18, 2018
- Initiation Date
- March 29, 2018
- Termination Date
- January 24, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,190 boxes
Product Description
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 Pattern
Nationwide within US
Code Information
Lot #:14122921, Exp.12/30/20119, 15091512, Exp. 9/15/2020, 6032321, Exp. 3/23/2021, 17030921, Exp. 3/09/2022