FDA-Drug2023-04-05Class II

Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx
Hazard

cGMP deviations

Sold states
Nationwide in the USA
Affected count
30 count: 4 bottles; 90 count: 172 bottles
Manufactured in
94 Worldwide Dr, N/A, Dawsonville, GA, United States
Products
Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0480-2023

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