Reported Jan 15, 2020 · Terminated

Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.

AAA Pharmaceutical, Inc.

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: AAA Pharmaceutical, Inc. · 681 Main St · Lumberton, NJ · 08048-5013

Is this the product you have?

    • Ranitidine 150 mg tablets
    • 24 count bottles
    • NDC 37808-196-01
Lot codes and dates
    • P134458
    • Sept 2020 P134943
    • Aug 2020 P135840
    • Aug
    • 2020 P136622
    • April 2021 P136871
    • April 2021 P137347
    • April 2021 P137424
    • April 2021
Amount recalled
34,272 (24-count bottles)

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 10, 2021 · Data as of Sep 19, 5:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.