Reported Dec 18, 2019 · Ongoing
Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
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 150 mg1000-count bottlesNDC 53746-253-10
- Lot codes and dates
HB03718A3/2020HB03818A3/2020HB03918A3/2020HB04018A3/2020HC01618A3/2020HC14618A5/2020HC14718A5/2020HC14818A5/2020HC14918A5/2020HC15018A5/2020HK02318A9/2020HK02418A9/2020HK02518A9/2020HK02618A9/2020HD03119A3/2021HD03219A3/2021HE03119A4/2021HE03219A4/2021
- 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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