FDA-Drug2020-04-15Class II
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 by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09
Avet Pharmaceuticals, Inc.
Hazard
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Sold states
Nationwide
Affected count
a) 2,904; b) 14,316; c) 1,368 bottles
Manufactured in
1 Tower Center Blvd Ste 1700, N/A, East Brunswick, NJ, United States
Products
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 by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1103-2020Don't want to check this manually?
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