FDA-Drug2023-04-05Class II
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
Direct Rx
Hazard
cGMP deviations
Sold states
Nationwide in the USA
Affected count
90 count: 495 bottles; 30 count: 13 bottles
Manufactured in
94 Worldwide Dr, N/A, Dawsonville, GA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0476-2023Don't want to check this manually?
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