FDA recall D-0382-2022

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

Product

Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, 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-0382-2022