FDA recall D-0268-2022

Dr. Reddy's Laboratories, Inc. · Class III · drug

Product

Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20

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-0268-2022