FDA recall D-0269-2022

Product

Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14.

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-0269-2022