Direct Rx recalls Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count
Recalled April 5, 2023 · FDA recall D-0476-2023 · Direct Rx
Hazard
cGMP deviations · FDA Class II
Units
90 count: 495 bottles; 30 count: 13 bottles
Sold at
Nationwide in the USA
Description
cGMP deviations
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
Manufacturer(s)
Direct Rx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →