Recalls / Class III
Class IIID-0324-2020
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,
- Brand name
- Wal-dram 2 Quick-dissolving
- Generic name
- Meclizine Hydrochloride
- Active ingredient
- Meclizine Hydrochloride
- Route
- Oral
- NDC
- 0363-1407
- FDA application
- M009
- Affected lot / code info
- Lot #: a) AXWA, Exp. date Feb 2021; AXAB, Exp. date May 2021; AXLK, Exp. date Nov 2021; b) AXZP, Exp. date Jul 2021
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Sato Pharmaceutical Inc.
- Manufacturer
- Walgreen Co.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20695 S Western Ave Ste 240, N/A, Torrance, California 90501-1834
Distribution
- Quantity
- a) 112,104 units b) 24,696 units
- Distribution pattern
- Nationwide within the United States, Guam and Saipan
Timeline
- Recall initiated
- 2019-10-01
- FDA classified
- 2019-11-13
- Posted by FDA
- 2019-11-20
- Terminated
- 2020-08-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0324-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.