Antacid tablets recalled after failing disintegration time specifications
Sato Pharmaceutical is recalling 3,640 bottles of INON ACE Antacid tablets after the lot failed disintegration specifications, taking longer than expected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a failed disintegration specification with no stated clinical consequence or reported harm.
Plain-English summary
INON ACE Antacid tablets, containing magnesium aluminosilicate, magnesium hydroxide and simethicone, in 75-count bottles under NDC 49873-402-01, are being recalled by Sato Pharmaceutical Co., Ltd.
The reason given in the enforcement record is failed disintegration specifications: above the time expected.
The record lists 3,640 bottles from lot PWXT, expiry 1/31/2027. Distribution was to California and Hawaii. The FDA has classified the action as Class II.
The record cites an out-of-specification disintegration time and names no clinical consequence. Consumers should follow the retailer's return instructions.
The recalled product
- Product
- INON ACE (MAGNESIUM ALUMINOSILICATES, MAGNESIUM HYDROXIDE, SIMETHICONE)
- Brand
- INON ACE
- Manufacturer
- Sato Pharmaceutical Co., Ltd
- Category
- Drug — Antacid
- Affected units
- 3,640
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: PWXT
- Exp 1/31/2027
UPCs (1)
- 0349873402017
Distribution
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