Losartan Potassium And Hydrochlorothiazide Tablet, Film Coated
FDA Recall NDC 59746-337
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 59746-337). A significant event, classified as Class II, was initiated on Jul 11, 2014 by Jubilant Cadista Pharmaceuticals Inc.. The reported reason for this action was: "Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel."
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
Class II Terminated
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Jul 11, 2014
Aug 06, 2014
9,358 bottles
Recall Profile & Regulatory Data
Event ID
68776
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Jubilant Cadista Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Sep 15, 2016
Product Description
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90
Batch or Lot Expiration Information
Lot# 14P0292, Exp 04/2016
Affected Packages Involved in this Recall
59746-337-30Product
59746-337-90Product
59746-337-01Product
59746-337-10Product
59746-338-30Product
59746-338-90Product
59746-338-01Product
59746-338-10Product
59746-339-30Product
59746-339-90Product
59746-339-01Product
59746-339-10Product
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.
