Reported May 29, 2019 · Terminated
Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited,…
Heritage 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: Heritage 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 90
- film coated tablets Manufactured byVivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India
- Manufactured forHeritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-09
- Lot codes and dates
- Lot CLO17009B exp 11/2019 Lot CLO17010A exp 11/2019 Lot CLO18023A exp 04/2020
- Amount recalled
- 34403 bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 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 at the manufacturer
This product could cause temporary or reversible health problems — stop using it.
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