FDA recall D-0380-2022

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

Product

Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, 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-0380-2022