FDA DrugsClass II
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and sim...
Published: February 4, 2026Recall ID: D-0298-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Disintegration Specifications: above the time expected.
Product Description & Identification
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
Additional Source Details
| Field | Value |
|---|---|
| City | Tokyo |
| State | N/A |
| Openfda › Nui | N0000010282 |
| Openfda › Upc | 0349873402017 |
| Openfda › Unii › 1 | 92RU3N3Y1O |
| Openfda › Unii › 2 | NBZ3QY004S |
| Openfda › Unii › 3 | 9T3UU8T0QK |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 1235450 |
| Openfda › Rxcui › 2 | 1235456 |
| Openfda › Spl id | 09d87d9c-fe4c-fd02-e063-6394a90a56bd |
| Openfda › Brand name | INON ACE |
| Openfda › Spl set id | 0af4355f-e160-409d-8471-2de98dbc6f7c |
| Openfda › Package ndc | 49873-402-01 |
| Openfda › Product ndc | 49873-402 |
| Openfda › Generic name | MAGNESIUM ALUMINOSILICATES, MAGNESIUM HYDROXIDE, SIMETHICONE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Pharm class pe | Skin Barrier Activity [PE] |
| Openfda › Substance name › 1 | DIMETHICONE |
| Openfda › Substance name › 2 | MAGNESIUM HYDROXIDE |
| Openfda › Substance name › 3 | SILODRATE |
| Openfda › Manufacturer name | Sato Pharmaceutical Co., Ltd. |
| Openfda › Application number | M001 |
| Openfda › Is original packager | true |
| Event id | 98216 |
| Address 1 | Ahc Building 1-5-27 |
| Address 2 | N/A |
| Code info | Lot#: PWXT, Exp 1/31/2027 |
| Postal code | N/A |
| Report date | 20260204 |
| Product type | Drugs |
| Product quantity | 3,640 bottles |
| Reason for recall | Failed Disintegration Specifications: above the time expected. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251219 |
| Initial firm notification | Letter |
| Center classification date | 20260127 |
Overview
- Recalling FirmSato Pharmaceutical Co., Ltd
- StatusOngoing
- Risk LevelClass II
- DistributionCA and HI