Reported Apr 15, 2020 · Terminated
Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count…
Avet 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: Avet Pharmaceuticals, Inc. · 1 Tower Center Blvd Ste 1700 · East Brunswick, NJ · 08816-1145
Is this the product you have?
- Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only
- Manufactured byVivimed Life Sciences Private Limited, Tamil Nadu, India
- Manufactured forHeritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09
- Lot codes and dates
a) CL018008Aexp Mar 2020b) CL018008Bexp Mar 2020c) CL018009Aexp Mar 2020
- Amount recalled
- a) 2,904; b) 14,316; c) 1,368 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
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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