Status
Terminated
Drug Enforcement D-0480-2023
cGMP deviations
Classification
Class II
Report Date
April 5, 2023
Termination Date
June 17, 2024
Product Information
- Product description
- 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
- Product quantity
- 30 count: 4 bottles; 90 count: 172 bottles
- Reason for recall
- cGMP deviations
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Direct Rx
- Address
-
94 Worldwide Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0480-2023
- Event ID
- 91921
- Recall initiation date
- March 13, 2023
- Center classification date
- March 24, 2023
- Code info
- a) [30 count bottles] Lot, expiry: 07MA2208, exp 5/31/2024 b) [90 count bottles] Lot, expiry: 09AU2128 , exp 1/31/2024; 28JY2102 , exp 1/31/2024; 06AU2103 , exp 1/31/2024 ; 03JA2210 , exp 1/31/2024 ; 14JY2114 , exp 1/31/2024 ; 05NO2106 , exp 2/29/2024 ; 13OC2118 , exp 2/29/2024 ; 08DE2121 , exp 2/29/2024 ;
- More code info
- —