Product Safety Recalls

Product Recall Tracker

Recall D-0482-2023

Description: Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Recall D-0482-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0482-2023
Event ID91921
DistributionNationwide in the USA
Quantity30 count: 7 bottles; 90 count: 395 bottles
Recall ReasoncGMP deviations
Drug ClassificationClass II
Drug Code Info20230405
Recall Initiation Date20230313
Report Date20230405
Classification Date20230324
Address94 Worldwide Dr
Dawsonville, GA 30534-6828
United States
Recalling FirmDirect Rx
Initial Notification Letter
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