Recall archive / FDA drug enforcement
Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC... — FDA record D-0485-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 13, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
- Reason
- cGMP deviations
- Classification
- Class II
- Recalling firm
- Direct Rx
- Quantity
- 30 count: 5 bottles; 90 count: 53 bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0485-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a) [30-count bottles] Lot, expiry: 09JA2312 , exp 2/28/2025; b) [90-count bottles] Lot, expiry: 22OC2111, exp 1/31/2023; 13OC2120, exp 3/31/2023; 16JY2104, exp 12/31/2023; 09AU2125 , exp 1/31/2024 ; 28JY2125 , exp 1/31/2024 ; 23SE2115 , exp 3/31/2024 ; 23SE2115 , exp 3/31/2024 ; 07JA2211 , exp 5/31/2024 ; 27JA2214 , exp 5/31/2024 ; 15AP2224 , exp 6/30/2024 ; 24MA2221 , exp 6/30/2024 ; 16AU2214 , exp 6/30/2024 . |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide in the USA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 5, 2023
- Recall initiation date
- Mar 13, 2023
- Center classification date
- Mar 24, 2023
- Termination date
- Jun 17, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.