FDA recall D-0267-2022

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

Product

Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Release Tablets, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-7388-5.

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-0267-2022