D-0324-2020 Class III Terminated
FDA drug recall D-0324-2020 was initiated by Sato Pharmaceutical Inc. on Oct 1, 2019 and is designated Class III. Reason for recall: Subpotent Drug The recall status is terminated (terminated Aug 18, 2020). Affected quantity: a) 112,104 units b) 24,696 units.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 20, 2019
- Initiation Date
- Oct 1, 2019
- Termination Date
- Aug 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 112,104 units b) 24,696 units
Product description
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 pattern
Nationwide within the United States, Guam and Saipan
Code information
Lot #: a) AXWA, Exp. date Feb 2021; AXAB, Exp. date May 2021; AXLK, Exp. date Nov 2021; b) AXZP, Exp. date Jul 2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0324-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026