Drug product

Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30

D-0018-2021

April 30, 2019

Class II

Product summary

Firm: Direct Rx
Event: Event 86499
Status: Terminated
Classification: Class II
Quantity: 33 bottles
Official record key: drug-enforcement:D-0018-2021

Official wording

Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer

Code information: Lot: 27AU1801 Exp. 02/28/2021

Distribution pattern: GA

Derived failure modes

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

impurity, N-Methylnitrosobutyric acid (NMBA
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations