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Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Release Tablets per box, NDC 0363-1606-30, Distributed by: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015, Made in India.

Drug Recall

Official source record

Recall number
D-0378-2022
Event ID
89364
Classification
Class III
Status
Terminated
Recalling company
Dr. Reddy's Laboratories, Inc.
Reason for recall
Failed Dissolution Specifications
Report date
January 26, 2022
Recall initiation date
January 4, 2022
Termination date
October 20, 2023
Distribution pattern
Nationwide in the USA

Drug product identifiers

Manufacturer
Walgreens Company
Brand name
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI
Generic name
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI
Substance names
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Product NDC
0363-1606
Package NDCs
0363-1606-20; 0363-1606-30
Route
ORAL

Where this information comes from

View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.

This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details, or FDA Enforcement Reports versus recall announcements for why that gap exists. New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class III mean?

FDA classifies this recall as Class III. See how to read an FDA recall record for what each classification level means.

Is this recall still active?

According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this medication?

Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.

Official guidance and record verification

Public Health Trace does not provide medical advice -- review the linked official source below for current, authoritative information.

How to interpret this historical record

This record is preserved as published by FDA, as of October 20, 2023.

Status as reported: Terminated.

This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.

View the official FDA source

Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.

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