Status
Terminated
Drug Enforcement D-0486-2023
cGMP deviations
Classification
Class II
Report Date
April 5, 2023
Termination Date
June 17, 2024
Product Information
- Product description
- Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
- Product quantity
- 269 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-0486-2023
- Event ID
- 91921
- Recall initiation date
- March 13, 2023
- Center classification date
- March 24, 2023
- Code info
- Lot, expiry: 28AP2212 , exp 7/31/2024 ; 24MA2230, exp 7/31/2024; 11JA2203 , exp 3/31/2023; 02FE2217 , exp 2/28/2023; 10DE2126 , exp 2/28/2023; 25MA2201, exp 5/31/2023; 28FE2230, exp 5/31/2023.
- More code info
- —