FDA-Drug2018-11-28Class II
Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA
Sciegen Pharmaceuticals Inc
Hazard
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Sold states
Nationwide
Affected count
2,977 HDPE bottles
Manufactured in
89 Arkay Dr, N/A, Hauppauge, NY, United States
Products
Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0267-2019Don't want to check this manually?
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