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Class II · ModerateActive recall

RANITIDINE TABLETS

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot number7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A
Where it was soldOR, NY, NJ
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forGranules India Limited
NDC62207-773-32
Show the full FDA record
Full product labelRANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Recalling firmGranules India Limited
DistributionOR, NY, NJ
Quantity23,090,000 tablets
Recall initiated2019-12-13
Report date2020-01-08
Recall completed—
Recall numberD-0632-2020
ClassificationClass II
FDA statusOngoing
Origin on fileQutbullapur Mandal, Ranga Redd N/A India

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.