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 TABLETSUSP 150mg10000-count bag
- Country of OriginINDIA NDC 62207-773-32
- Lot codes and dates
7730001A7730002A7730003A7730004A7730005A7730006A7730007A7730008A7730009A7730010A7730011A 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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