Home / Recalls / Direct Rx / D-0018-2021

D-0018-2021 Class II Terminated

Recalled by Direct Rx — Dawsonville, GA

Recall Details

Product Type
Drugs
Report Date
October 14, 2020
Initiation Date
April 30, 2019
Termination Date
December 4, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
33 bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

GA

Code Information

Lot: 27AU1801 Exp. 02/28/2021

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