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Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extend...

FDA Recall #D-0270-2022 — Class III — November 12, 2021

Recall #D-0270-2022 Date: November 12, 2021 Classification: Class III Status: Terminated

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

Recalling Firm

Dr. Reddy's Laboratories, Inc. — Princeton, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

2352 cartons

Distribution

USA Nationwide.

Code Information

Lot #: AC2103329H, Exp 1/2023

Status

Terminated

Voluntary / Mandated

N/A

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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