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Recall Observatory FDA recall evidence

Drug product

GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.

D-0270-2019

October 29, 2018

Class II

Product summary

Firm
Sciegen Pharmaceuticals Inc
Event
Event 81458
Status
Terminated
Classification
Class II
Quantity
3,835 HDPE bottles
Official record key
drug-enforcement:D-0270-2019

Official wording

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

Code information: 60429-640-90 Irbesartan 75mg Tablets, 90 Count Bottle B160003 Sep-19 B160004 Sep-19

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