Sato Pharmaceutical Co., Ltd: INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceut
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Sato Pharmaceutical Co., Ltd
- Product
- INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
- Reason / hazard
- Failed Disintegration Specifications: above the time expected.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- CA and HI
- Recall initiated
- 2025-12-19
- Code info
- Lot#: PWXT, Exp 1/31/2027
- Product quantity
- 3,640 bottles
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Tokyo
- State
- N/A
- Country
- Japan
- Event id
- 98216
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