FDA recall D-0275-2022

Product

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

Distribution

USA Nationwide.

Key facts

Status

Terminated

Initiation date

2021-11-12

Report date

2021-12-15

Termination date

2023-06-23

Voluntary/Mandated

N/A

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0275-2022