Reported Apr 5, 2023 · Terminated
Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC…
Direct Rx
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Direct Rx · 94 Worldwide Dr · Dawsonville, GA · 30534-6828
Is this the product you have?
- 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 ByDirect Rx, Dawsonville, GA 30534
- Lot codes and dates
- a) [30-count bottles] Lot
- expiry
09JA2312exp 2/28/2025b) [90-count bottles] Lot
- expiry
22OC2111exp 1/31/202313OC2120exp 3/31/202316JY2104exp 12/31/202309AU2125exp 1/31/202428JY2125exp 1/31/202423SE2115exp 3/31/202423SE2115exp 3/31/202407JA2211exp 5/31/202427JA2214exp 5/31/202415AP2224exp 6/30/202424MA2221exp 6/30/202416AU2214exp 6/30/2024
- Amount recalled
- 30 count: 5 bottles; 90 count: 53 bottles
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
cGMP deviations
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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