FDA recall D-0379-2022

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

Product

Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2022-01-04
Report date: 2022-01-26
Termination date: 2023-10-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0379-2022