Reported Dec 18, 2019 · Ongoing
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Amneal Pharmaceuticals, 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: Amneal Pharmaceuticals, Inc. · 50 Horseblock Rd · Brookhaven, NY · 11719-9509
Is this the product you have?
Ranitidine TabletsUSP 300 mg250-count bottlesNDC 53746-254-02
- Lot codes and dates
HB04118A2/2020HB04218A2/2020HB04318A2/2020HB04418A2/2020HF13518A6/2020HF13618A6/2020HF13718A6/2020HF13818A6/2020HK02818A9/2020HK02918A9/2020HK03018A9/2020HK03118A9/2020HL08418A11/2020HL08518A11/2020HL08618A11/2020HL08718A11/2020HB01419A1/2021HB05619A1/2021HB05719A1/2021HB05819A1/2021HB05919A1/2021HB06019A1/2021HB06119A1/2021
- Amount recalled
- N/A
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are 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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