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Class II: temporary or reversible health riskTerminated

Sandoz Ranitidine Hydrochloride Capsules Recall

Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by San…

Sandoz, Inc · Princeton, NJ

Risk level
Class II
Reported by FDA
Oct 16, 2019
Recall ID
D-0128-2020
Check your lot numberHow we source this data

Summary

Sandoz recalled Sandoz Ranitidine Hydrochloride Capsules starting Sep 23, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0128-2020 on Oct 16, 2019. Reason: CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). Status: Terminated.

Why it was recalled

CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

Product description

Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05

Lot numbers, UPCs & expiration codes

HD1862 4/30/2020 HP9438 9/30/2020 HP9439 9/30/2020 HP9440 9/30/2020

Where it was sold

U.S. Nationwide

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-0128-2020
Classification
Class II
Status
Terminated
Recall initiated
Sep 23, 2019
FDA report date
Oct 16, 2019
Quantity
13,130 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Sandoz, Inc

Original FDA data

Every field from FDA enforcement report D-0128-2020, exactly as published.

Show all FDA fields
City
Princeton
State
NJ
Status
Terminated
Country
United States
Event ID
83875
Address
506 Carnegie Ctr Ste 400
Code information
HD1862 4/30/2020 HP9438 9/30/2020 HP9439 9/30/2020 HP9440 9/30/2020
Postal code
08540-6243
Report date
Oct 16, 2019
Product type
Drugs
Recall number
D-0128-2020
Classification
Class II
Recalling firm
Sandoz, Inc
Product quantity
13,130 bottles
Termination date
Jul 14, 2023
Reason for recall
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Voluntary / mandated
Voluntary: Firm initiated
Product description
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05
Distribution pattern
U.S. Nationwide
Recall initiation date
Sep 23, 2019
Initial firm notification
Press Release
Center classification date
Oct 7, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0128-2020, published Oct 16, 2019. 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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