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Granules recalls
FDA enforcement reports naming Granules USA, Inc. as the recalling firm.
Recall reports
1
Class I (serious)
0
Most recent report
Sep 8, 2021
All
1
Food
0
Drugs
1
Severity
All classes
Class I: serious
Class II: moderate
Class III: low
Date
Product
Reason
Class
Sep 8, 2021
Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy
Drug ยท Granules USA, Inc.
CGMP Deviations
Class II