Direct Rx: Drug Recall

Recall #D-0893-2022 · 05/11/2022

Class II: Risk

Recall Details

Recall Number: D-0893-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Direct Rx
Status: Terminated
Date Initiated: 05/11/2022
Location: Dawsonville, GA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11 bottles

Reason for Recall

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

Product Description

Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

Distribution Pattern

Other Recalls by Direct Rx

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CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
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CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II: Risk 01/31/2025

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II: Risk 08/09/2024

Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Class II: Risk 03/22/2023

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

View all recalls by Direct Rx →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.