Reported Apr 15, 2020 · Terminated
Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and…
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 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only
- Manufactured byVivimed Life Sciences Private Limited, Tamil Nadu
- India Manufactured forHeritage Pharmaceutical Inc., East Brunswick, NJ 08816
- Lot codes and dates
a) CL018022Bexp Apr 2020 b) CL018010A Mar 2020CL018017BCL018018A exp Apr 2020 c) CL018011ACL018012A exp Mar 2020CL018013ACL018015ACL018016ACL018017Aexp Apr 2020
- Amount recalled
- a) 12,168; b) 17,196; c) 3,890
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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