PlainRecalls
FDA Drug Low Class III Terminated

Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34.

Reported: December 15, 2021 Initiated: November 12, 2021 #D-0270-2022

Product Description

Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34.

Reason for Recall

Failed dissolution specifications

Details

Units Affected
2352 cartons
Distribution
USA Nationwide.
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 2352 cartons.
Why was this product recalled?
Failed dissolution specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on December 15, 2021. Severity: Low. Recall number: D-0270-2022.