Drug product
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
D-0482-2023
Product summary
- Firm
- Direct Rx
- Event
- Event 91921
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 count: 7 bottles; 90 count: 395 bottles
- Official record key
drug-enforcement:D-0482-2023
Official wording
Reason: cGMP deviations
Code information: a) [30 count bottles] Lot, expiry: 13DE2111 , exp 3/31/2024 b) [90 count bottles] Lot, expiry: 17NO2116 , exp 1/31/2024 ; 27JA2234 , exp 4/30/2024; 02MA2218, exp 6/30/2024 ; 12MY2211, exp 7/31/2024 ; 13JY2107, exp 10/31/2023; 15AP2221 , exp 7/31/2024 ; 17AU2110 , exp 10/31/2023; 20SE2108 , exp 10/31/2023; 23JU2115 , exp 10/31/2023; 28JY2101 ,exp 10/31/2023; 30JY2101 ,exp 10/31/2023; 05JA2212 , exp 3/31/2024 ; 13DE2130 , exp 3/31/2024 ; 21OC2111, exp 1/31/2024 ; 17NO2116 , exp 3/31/2024 .
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
cGMP deviations