FDAClass IIIJanuary 26, 2022

Rugby, Antihistamine and Nasal Decongestant recall: Failed Dissolution

Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.

Why was Rugby, Antihistamine and Nasal Decongestant recalled?

Failed Dissolution Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: AC2106452F, Exp. 3/31/2023

Product
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
2,352 boxes
Distribution
Nationwide in the USA
Recall date
January 26, 2022
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls