Multi event Drug Recall Enforcement Report Class III voluntary initiated by Sato Pharmaceutical Inc., originally initiated on 10-01-2019 for the 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, The product was recalled due to subpotent drug. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0324-2020 | 10-01-2019 | 11-20-2019 | Class III | a) 112,104 units b) 24,696 units | 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, | Subpotent Drug | Terminated |
| D-0325-2020 | 10-01-2019 | 11-20-2019 | Class III | 39,504 units | Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 69842-288-01. UPC 5042849946 | Subpotent Drug | Terminated |
| D-0322-2020 | 10-01-2019 | 11-20-2019 | Class III | 21,864 units | Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 49873-803-01. UPC 4987301603 | Subpotent Drug | Terminated |
| D-0323-2020 | 10-01-2019 | 11-20-2019 | Class III | 210,744 units | Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 59779-534-01. UPC 050428345535 | Subpotent Drug | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0363-1407 | Wal-dram 2 Quick-dissolving | Meclizine Hydrochloride | Tablet, Orally Disintegrating | Oral | Walgreen Co. | Human Otc Drug |
| 59779-534 | Cvs Motion Sickness Fast Melting | Meclizine Hydrochloride | Tablet, Orally Disintegrating | Oral | Cvs Pharmacy, Inc. | Human Otc Drug |
