Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and ...

FDA Recall #D-0275-2022 — Class III — November 12, 2021

Recall #D-0275-2022 Date: November 12, 2021 Classification: Class III Status: Terminated

Product Description

Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31.

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

2,928 cartons

Distribution

USA Nationwide.

Code Information

Lot #: AC2103329A

Status

Terminated

Voluntary / Mandated

N/A