Wal-dram 2 Quick-dissolving Tablet, Orally Disintegrating
FDA Recall NDC 0363-1407
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Wal-dram 2 Quick-dissolving (NDC 0363-1407). A significant event, classified as Class III, was initiated on Oct 01, 2019 by Walgreen Co.. The reported reason for this action was: "Subpotent Drug"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent Drug
Oct 01, 2019
Nov 20, 2019
a) 112,104 units b) 24,696 units
Recall Profile & Regulatory Data
Event ID
83964
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sato Pharmaceutical Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States, Guam and Saipan
Termination Date
Aug 18, 2020
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,
Batch or Lot Expiration Information
Lot# : a) AXWA, Exp. date Feb 2021; AXAB, Exp. date May 2021; AXLK, Exp. date Nov 2021; b) AXZP, Exp. date Jul 2021
Affected Packages Involved in this Recall
0363-1407-01Product
0363-1407-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
