Drug product
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
D-0298-2026
Product summary
- Event
- Event 98216
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,640 bottles
- Official record key
drug-enforcement:D-0298-2026
Official wording
Reason: Failed Disintegration Specifications: above the time expected.
Code information: Lot#: PWXT, Exp 1/31/2027
Distribution pattern: CA and HI
Derived failure modes
-
Unknown
Failed Disintegration Specifications: above the time expected.