Drug 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,
D-0324-2020
Product summary
- Event
- Event 83964
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 112,104 units b) 24,696 units
- Official record key
drug-enforcement:D-0324-2020
Official wording
Reason: Subpotent Drug
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
Distribution pattern: Nationwide within the United States, Guam and Saipan
Derived failure modes
-
Potency or specification failure
Subpotent