Losartan Potassium Tablet, Film Coated
FDA Recall NDC 42571-112
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 (NDC 42571-112). A significant event, classified as Class II, was initiated on Sep 22, 2014 by Micro Labs Limited. The reported reason for this action was: "Failed Content Uniformity Specifications; Dry mix failed blend uniformity."
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
September 2014 Class II Recall: Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
Recall Number
Class II Terminated
Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
Sep 22, 2014
Nov 26, 2014
144 bottles
Recall Profile & Regulatory Data
Event ID
69590
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Micro Labs Usa, Inc S
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Including: New York
Termination Date
Dec 22, 2015
Product Description
LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10
Batch or Lot Expiration Information
Lot# LJAG003, Expiry: 05/2015
Affected Packages Involved in this Recall
42571-110-30Product
42571-110-90Product
42571-110-10Product
42571-111-30Product
42571-111-90Product
42571-111-10Product
42571-112-30Product
42571-112-90Product
42571-112-10Product
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.
