Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP,
Summary
The FDA issued a Class III for Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine H by Dr. Reddy's Laboratories, Inc.. Reason: Failed dissolution specifications.
Details
Source
Drug Recall
External ID
D-0271-2022
Action Date
2021-12-15
Status
Terminated
Category
drug
Product Description
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07.
Lot/Code Info: Lot #: AC2103329D, Exp 1/2023
Quantity Affected: 2184 cartons
Reason for Recall
Failed dissolution specifications
Distribution
USA Nationwide.
Type: N/A
Recall Initiated: 2021-11-12
Company
Princeton, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 28 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dr. Reddy's Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dr. Reddy's Laboratories, Inc. have FDA actions?
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0271-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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