November 2022 FDA Recall Drug by Dr. Reddy's Laboratories, Inc.
D-0073-2023 - Failed dissolution specifications

This Class III drug recall was initiated by Dr. Reddy's Laboratories, Inc. on November 21, 2022 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0073-2023

Reason for Recall
Failed dissolution specifications
Initiated
11-21-2022
Reported
12-07-2022
Quantity
25,176, 30-count; 22,968 20-count

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91190
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-28-2024
Product Description About Product Description
Full technical description of the product.
Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packaged as (a) 20 count carton NDC 49032-273-20; (b) 30 count carton, NDC49032-273-30; Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India

Batch or Lot Expiration Information

Lot# (a) AC2203133B, EXP 01/2024; (b) AC2203133A, EXP 01/2024.