Status
Terminated
Drug Enforcement D-0484-2023
cGMP deviations
Classification
Class II
Report Date
April 5, 2023
Termination Date
June 17, 2024
Product Information
- Product description
- Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
- Product quantity
- 30 count: 6 bottles; 90 count: 106 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-0484-2023
- Event ID
- 91921
- Recall initiation date
- March 13, 2023
- Center classification date
- March 24, 2023
- Code info
- a) [30-count bottles] Lot, expiry: 05AU2206, exp 10/31/23; b) [90-count bottles] Lot, expiry: 30MA2213, exp 6/30/23; 10DE2124, exp 3/31/23; 15MA2224, exp 5/32/23; 27JA2229, exp 3/31/23.
- More code info
- —