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Granules India Limited

1 ongoing recall currently shown

Based on the official records currently available to Public Health Trace, 1 recall naming Granules India Limited is currently shown as ongoing.

Public Health Trace has 1 recall naming Granules India Limited as the recalling firm, republished from official FDA and USDA sources.

Recall records - 1 total

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20201
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FDA Recall OngoingHistorical recordClass II

RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32

by Granules India Limited

Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Published
January 8, 2020
Distribution
Multiple states

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Some FDA recall records on this page come from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

This page lists recalls that name Granules India Limited as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.