Class III · Low risk
Magnesium Chloride
Subpotent drug
INON ACE Antacid tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Disintegration Specifications: above the time expected.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
Affected NDC
49873-0402-01
Compare with the code on your package — it is the most precise check available.
Drug: Magnesium
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 |
|---|---|---|---|---|
| Inon Ace magnesium aluminosilicates, magnesium hydroxide, simethicone NDC 49873-0402 |
MAGNESIUM HYDROXIDE 60 mg/1; SILODRATE 200 mg/1; DIMETHICONE 20 mg/1 | Tablet Oral |
Sato Pharmaceutical Co., Ltd. | OTC |
- Recalling firm
- Sato Pharmaceutical Co., Ltd
- NDC code
- 49873-402-01
- Origin
- N/A, Japan
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0298-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Magnesium recalls
See all
Class I · High risk
Magnesium Sulfate in Water for Injection
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Class II · Moderate risk
Magnesium Chloride for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione Magnesium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Other recalls by Sato Pharmaceutical Co., Ltd
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