Losartan Potassium Tablet, Film Coated
FDA Recall NDC 43063-854
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 43063-854). A significant event, classified as Class II, was initiated on Mar 08, 2019 by Pd-rx Pharmaceuticals, Inc.. The reported reason for this action was: "CGMP deviation: Product found to contain trace amounts of NMBA"
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
CGMP deviation: Product found to contain trace amounts of NMBA
Mar 08, 2019
May 05, 2021
576 bottles
Recall Profile & Regulatory Data
Event ID
87774
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
PD-Rx Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY
Termination Date
Jun 16, 2021
Product Description
Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-90
Batch or Lot Expiration Information
Lot# Lots: A19B99 Exp. 11/30/2019; B19A26 Exp. 11/30/2019; B19A69 Exp. 11/30/2019; E18F12 Exp.: 09/30/19; F18A12 Exp.: 09/30/19; F18F06 Exp.: 09/30/19; G18B43 Exp.: 09/30/19; G18C43 Exp.: 09/30/19; G18F75 Exp.: 09/30/19; H18D55 Exp.: 09/30/19; I18A11 Exp.: 09/30/19; I18E32 Exp.: 09/30/19; J18A90 Exp.: 09/30/19; J18D50 Exp. 11/30/2019; L18D01 Exp. 11/30/2019
Affected Packages Involved in this Recall
43063-854-60Product
43063-854-90Product
43063-0854-90Product
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.
