Home / Recalls / Direct Rx / D-0895-2022

D-0895-2022 Class II Terminated

Recalled by Direct Rx — Dawsonville, GA

Recall Details

Product Type: Drugs
Report Date: June 1, 2022
Initiation Date: May 11, 2022
Termination Date: December 2, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11 bottles

Product Description

Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

Reason for Recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

Distribution Pattern

Code Information

Lots: 08NO2102 Exp. 1/31/25; 17NO2118 Exp. 1/31/25; 18NO2123 Exp. 1/31/25; 25OC2114 Exp. 1/31/25; 22NO2105 Exp. 1/31/25

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