FDA recall D-0476-2023

Direct Rx · Class II · drug

Product

Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Reason for recall

cGMP deviations

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2023-03-13
Report date: 2023-04-05
Termination date: 2024-06-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0476-2023