Recall D-0481-2023
Description: Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Recall D-0481-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0481-2023 |
Event ID | 91921 |
Distribution | Nationwide in the USA |
Quantity | 30 count: 12 bottles; 90 count: 253 bottles |
Recall Reason | cGMP deviations |
Drug Classification | Class II |
Drug Code Info | 20230405 |
Recall Initiation Date | 20230313 |
Report Date | 20230405 |
Classification Date | 20230324 |
Address | 94 Worldwide Dr Dawsonville, GA 30534-6828 United States |
Recalling Firm | Direct Rx |
Initial Notification | Letter |
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