Drug product

Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA.

D-0269-2019

October 29, 2018

Class II

Product summary

Firm: Sciegen Pharmaceuticals Inc
Event: Event 81458
Status: Terminated
Classification: Class II
Quantity: 5,989 HDPE
Official record key: drug-enforcement:D-0269-2019

Official wording

Reason: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Code information: 69367-121-01 Irbesartan 300mg Tablets, 30 count bottle B162008A Sep-19 C162002A Feb-20 69367-121-03 Irbesartan 300mg Tablets, 90 count bottle B162008B Sep-19 C162002B Feb-20

Distribution pattern: Nationwide

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

impurity, N-nitrosodimethylamine (NDEA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations