Reported Jan 8, 2020 · Ongoing

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

Granules India Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Granules India Limited · Plot No. 160/A, 161/E, 162 and 174/A · Qutbullapur Mandal, Ranga Redd, N/A · N/A

Is this the product you have?

    • RANITIDINE TABLETS
    • USP 150mg
    • 10
    • 000-count bag
  • Country of OriginINDIA NDC 62207-773-32
Lot codes and dates
    • 7730001A
    • 7730002A
    • 7730003A
    • 7730004A
    • 7730005A
    • 7730006A
    • 7730007A
    • 7730008A
    • 7730009A
    • 7730010A
    • 7730011A and 7730012A
Amount recalled
23,090,000 tablets

Where it was sold

Why it was recalled

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:02 PM UTC

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