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 mga) 60 Tabs (NDC 61919-339-60)and b) 90 Tabs (NDC 61919-339-90) bottlesRx only
- Packaged and Distributed ByDirect Rx Dawsonville, GA 30534
- Lot codes and dates
- Lots
a) 09AU1911 Exp. 02/28/2022b) 09SE1904 Exp. 03/31/2022
- Lots
- 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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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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