Product: Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only  Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108  SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India.   Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784)  NDC 23155-645-10
Reason for recall: 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
Recall initiated: 20190503
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated