Why it was recalled
Subpotent Drug
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,
Lot numbers, UPCs & expiration codes
Lot #: a) AXWA, Exp. date Feb 2021; AXAB, Exp. date May 2021; AXLK, Exp. date Nov 2021; b) AXZP, Exp. date Jul 2021
Where it was sold
Nationwide within the United States, Guam and Saipan
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0324-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 1, 2019
- FDA report date
- Nov 20, 2019
- Quantity
- a) 112,104 units b) 24,696 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sato Pharmaceutical Inc.
Original FDA data
Every field from FDA enforcement report D-0324-2020, exactly as published.
Show all FDA fields
- City
- Torrance
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 83964
- Address
- 20695 S Western Ave Ste 240
- 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
- Postal code
- 90501-1834
- Report date
- Nov 20, 2019
- Product type
- Drugs
- Recall number
- D-0324-2020
- Classification
- Class III
- Recalling firm
- Sato Pharmaceutical Inc.
- Product quantity
- a) 112,104 units b) 24,696 units
- Termination date
- Aug 18, 2020
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- 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,
- Distribution pattern
- Nationwide within the United States, Guam and Saipan
- Recall initiation date
- Oct 1, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 13, 2019