Status
Terminated
Drug Enforcement D-0482-2023
cGMP deviations
Classification
Class II
Report Date
April 5, 2023
Termination Date
June 17, 2024
Product Information
- Product 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
- Product quantity
- 30 count: 7 bottles; 90 count: 395 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-0482-2023
- Event ID
- 91921
- Recall initiation date
- March 13, 2023
- Center classification date
- March 24, 2023
- Code info
- 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 .
- More code info
- —