Recalls / Class II
Class IID-0486-2023
Product
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
- Affected lot / 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.
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Direct Rx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, N/A, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 269 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-13
- FDA classified
- 2023-03-24
- Posted by FDA
- 2023-04-05
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0486-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.