Granules India recalls

FDA enforcement reports naming Granules India Limited as the recalling firm.

Recall reports: 1
Class I (serious): 0
Most recent report: Jan 8, 2020

Severity

Jan 8, 2020RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-77…Drug · Granules India LimitedCGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in APIClass II