FDA recall D-0271-2022

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

Product

Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07.

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-0271-2022