Multi event Drug Recall Enforcement Report Class III voluntary initiated by Sato Pharmaceutical Inc., originally initiated on 10-01-2019 for the product 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 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-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-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-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 |
