FDA-Drug2019-07-17Class II
Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
MAJOR PHARMACEUTICALS
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 at the manufacturer
Sold states
Nationwide.
Affected count
3,102 Cartons (310,200 tablets)
Manufactured in
17177 N Laurel Park Dr, Livonia, MI, United States
Products
Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1466-2019Don't want to check this manually?
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