Fexofenadine Hcl And Pseudoephedrine Hci Tablet, Extended Release
FDA Recall NDC 43598-823
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Fexofenadine Hcl And Pseudoephedrine Hci (NDC 43598-823). A significant event, classified as Class III, was initiated on Nov 12, 2021 by Dr. Reddy's Laboratories Inc.. The reported reason for this action was: "Failed dissolution specifications"
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 III Terminated
Failed dissolution specifications
Nov 12, 2021
Dec 15, 2021
2,928 cartons
Recall Profile & Regulatory Data
Event ID
89042
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
N/A
Distribution Pattern
USA Nationwide.
Termination Date
Jun 23, 2023
Product Description
Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31.
Batch or Lot Expiration Information
Lot# : AC2103329A
Affected Packages Involved in this Recall
43598-823-14Product
43598-823-31Product
43598-823-35Product
Class III Terminated
Failed dissolution specifications
Nov 12, 2021
Dec 15, 2021
5016 cartons
Recall Profile & Regulatory Data
Event ID
89042
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
N/A
Distribution Pattern
USA Nationwide.
Termination Date
Jun 23, 2023
Product Description
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14.
Batch or Lot Expiration Information
Lot# : AC2103329F, Exp 1/2023
Affected Packages Involved in this Recall
43598-823-14Product
43598-823-31Product
43598-823-35Product
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.
