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Class II: temporary or reversible health riskOngoing

Granules India Ranitidine Tablets Recall

RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-77…

Granules India Limited · Qutbullapur Mandal, Ranga Redd, N/A

Risk level
Class II
Reported by FDA
Jan 8, 2020
Recall ID
D-0632-2020
Check your lot numberHow we source this data

Summary

Granules India recalled Ranitidine Tablets starting Dec 13, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0632-2020 on Jan 8, 2020. Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. Status: Ongoing.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A

Where it was sold

OR, NY, NJ

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0632-2020
Classification
Class II
Status
Ongoing
Recall initiated
Dec 13, 2019
FDA report date
Jan 8, 2020
Quantity
23,090,000 tablets
Recall type
Voluntary: Firm initiated
Recalling firm
Granules India Limited

Original FDA data

Every field from FDA enforcement report D-0632-2020, exactly as published.

Show all FDA fields
City
Qutbullapur Mandal, Ranga Redd
Status
Ongoing
Country
India
Event ID
84522
Address
Plot No. 160/A, 161/E, 162 and 174/A
Address (line 2)
Gagillapur Village
Code information
7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A
Report date
Jan 8, 2020
Product type
Drugs
Recall number
D-0632-2020
Classification
Class II
Recalling firm
Granules India Limited
Product quantity
23,090,000 tablets
Reason for recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Voluntary / mandated
Voluntary: Firm initiated
Product description
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Distribution pattern
OR, NY, NJ
Recall initiation date
Dec 13, 2019
Initial firm notification
Letter
Center classification date
Dec 29, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0632-2020, published Jan 8, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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