Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated
FDA Recall NDC 72189-129
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 72189-129). A significant event, classified as Class II, was initiated on May 05, 2022 by Direct_rx. 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 05, 2022
Jun 08, 2022
81 bottles
Recall Profile & Regulatory Data
Event ID
90161
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Direct Rx
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
AL, GA, FL, LA
Termination Date
Oct 05, 2023
Product Description
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
Batch or Lot Expiration Information
Lot# a) 30-count bottles- Lot: 11MY2103 Exp. 11/30/22 Lot: 05JA2106 Exp. 6/30/22 b) 90-count bottles- Lot: 20MY2115 Exp. 11/30/22 Lot: 22JU2118 Exp. 12/31/22 Lot: 29JY2113 Exp. 12/31/22 Lot: 13SE2113 Exp. 2/28/23 Lot: 05JA2106 Exp. 6/30/22
Affected Packages Involved in this Recall
72189-012-90Product
72189-098-90Product
72189-129-90Product
72189-129-30Product
72189-139-30Product
72189-139-90Product
72189-167-30Product
72189-167-90Product
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.
