FDAHealthDecember 19, 2025
Sato Pharmaceutical Co., Ltd — INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402
⚠️ Failed Disintegration Specifications: above the time expected.
Is this relevant to me?
- Geography
- CA, HI
- Source agency
- FDA
- Category
- Health
- Published
- December 19, 2025
CA and HI
What's affected?
- Product
- INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
- Brand
- INON ACE
- UPC
- 0349873402017
- Lot code
- PWXT
Additional details
Lot#: PWXT, Exp 1/31/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3,640 bottles.
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