FDA Drug Recalls

Recalls / Class III

Class IIID-0073-2023

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

Affected lot / code info
Lot# (a) AC2203133B, EXP 01/2024; (b) AC2203133A, EXP 01/2024.

Why it was recalled

Failed dissolution specifications

Recalling firm

Firm
Dr. Reddy's Laboratories, Inc.
Notification channel
Letter
Address
107 College Rd E, Princeton, New Jersey 08540-6623

Distribution

Quantity
25,176, 30-count; 22,968 20-count
Distribution pattern
Nationwide in the USA

Timeline

Recall initiated
2022-11-21
FDA classified
2022-11-30
Posted by FDA
2022-12-07
Terminated
2024-08-28
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0073-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls