FDAFDA · Food and drugs·Recall number D-0485-2023
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
Published April 5, 2023 · Recall initiated: March 13, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Direct Rx
- Distributor
- Nationwide in the USA
- Lot
- 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 .
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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