Class II · Moderate risk
Meclizine Hydrochloride Tablets
Failed tablet specifications.
Wal-Dram 2 (Meclizine Hydrochloride)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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,
Affected NDCs
0363-1407-01
0363-1407-02
Compare with the code on your package — it is the most precise check available.
Drug: Meclizine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Wal-Dram 2 Quick-Dissolving meclizine hydrochloride NDC 00363-1407 |
25 mg/1 | Tablet, Orally Disintegrating Oral |
Walgreen Co. | OTC |
- Recalling firm
- Sato Pharmaceutical Inc.
- NDC code
- 0363-1407-01
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0324-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Meclizine recalls
See all
Class II · Moderate risk
Meclizine Hydrochloride Tablets
cGMP deviations: Temperature abuse
Class I · High risk
Meclizine Hydrochloride Tablets USP
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Class II · Moderate risk
Meclizine HCl Tablets
Labeling: Incorrect Instructions
Class II · Moderate risk
Meclizine HCl Tablets
Failed Dissolution Specifications
Other recalls by Sato Pharmaceutical Inc.
All 2019 recalls
Class II · Moderate risk
INON ACE Antacid tablets
Failed Disintegration Specifications: above the time expected.
Class III · Low risk
Motion Sickness Strips
Subpotent Drug
Class III · Low risk
Motion Sickness
Subpotent Drug
Class III · Low risk
Zentrip (meclizine Hydrochloride)
Subpotent Drug
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