Status
Terminated
Drug Enforcement D-0481-2023
cGMP deviations
Classification
Class II
Report Date
April 5, 2023
Termination Date
June 17, 2024
Product Information
- Product 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
- Product quantity
- 30 count: 12 bottles; 90 count: 253 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-0481-2023
- Event ID
- 91921
- Recall initiation date
- March 13, 2023
- Center classification date
- March 24, 2023
- Code info
- a) [30 count bottles] Lot, expiry: 21JU2112 , exp 9/30/2023 b) [90 count bottles] Lot, expiry: 22DE2113 , exp 1/31/2024; 27JA2235 , exp 3/31/2024; 05AP2224 , exp 7/31/2024 ; 06AU2104 , exp 1/31/2024 ; 08JU2215 , exp 9/30/2024 ; 209AU2109 , exp 1/31/2024 ; 15JU2113 , exp 9/30/2023 ; 21FE2217 , exp 4/30/2024 ; 21OC2115 , exp 2/29/2024 ; 23JY2144 , exp 1/31/2024 ; 25JU2124 , exp 9/30/2023 ; 29AP2219 , exp 7/31/2024 ; 07DE2128 , exp 3/31/2024 .
- More code info
- —