Reported Oct 14, 2020 · Terminated

Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and…

Direct Rx

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: Direct Rx · 94 Worldwide Dr · Dawsonville, GA · 30534-6828

Is this the product you have?

    • Ranitidine 150 mg
    • a) 60 Tabs (NDC 61919-339-60)
    • and b) 90 Tabs (NDC 61919-339-90) bottles
    • Rx only
  • Packaged and Distributed ByDirect Rx Dawsonville, GA 30534
Lot codes and dates
  • Lots
    • a) 09AU1911 Exp. 02/28/2022
    • b) 09SE1904 Exp. 03/31/2022
Amount recalled
a) 54 bottles; b) 26 bottles

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 7, 2020 · Data as of Sep 19, 8:38 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.