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Recall Observatory FDA recall evidence

Drug product

Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10.

D-0359-2019

November 01, 2018

Class II

Product summary

Firm
Sandoz, Inc
Event
Event 81485
Status
Ongoing
Classification
Class II
Quantity
170 HDPE bottles
Official record key
drug-enforcement:D-0359-2019

Official wording

Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Code information: Lot #: JB8912; Exp. 06/2020

Distribution pattern: OH, PR

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