Skip to content
Recall Observatory FDA recall evidence

Drug product

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

D-0263-2019

November 02, 2018

Class II

Product summary

Firm
Golden State Medical Supply Inc.
Event
Event 81500
Status
Terminated
Classification
Class II
Quantity
2,439 bottles
Official record key
drug-enforcement:D-0263-2019

Official wording

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

Code information: Lot Numbers: B160003; Exp. 09/19 B160004; Exp. 09/19

Distribution pattern: Product was distributed throughout the United States.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    impurity, N-nitrosodiethylamine (NDEA
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations