Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated
FDA Recall NDC 72189-290
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Losartan Potassium And Hydrochlorothiazide (NDC 72189-290). A significant event, classified as Class II, was initiated on May 11, 2022 by Directrx. The reported reason for this action was: "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits ."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
May 2022 Class II Recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Recall Number
Class II Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
May 11, 2022
Jun 01, 2022
11 bottles
Recall Profile & Regulatory Data
Event ID
90200
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Direct Rx
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL
Termination Date
Dec 02, 2022
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
Batch or Lot Expiration Information
Lot# Lot: 25OC2116 Exp. 5/31/23
Affected Packages Involved in this Recall
72189-290-90Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
