FDA recall D-0324-2020

Product

WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (NDC 0363-1407-01, UPC 3 11917-18328 2 ) and b) 18-count boxes (NDC 0363-1407-02, UPC 3 11917-20318 8) Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501,

Reason for recall

Subpotent Drug

Distribution

Nationwide within the United States, Guam and Saipan

Key facts

Status

Terminated

Initiation date

2019-10-01

Report date

2019-11-20

Termination date

2020-08-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Torrance, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0324-2020