Reported Apr 5, 2023 · Terminated
Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle,…
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, 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 ByDirect Rx, Dawsonville, GA 30534
- Lot codes and dates
- a) [30-count bottles] Lot
- expiry
05AU2206exp 10/31/23b) [90-count bottles] Lot
- expiry
30MA2213exp 6/30/2310DE2124exp 3/31/2315MA2224exp 5/32/2327JA2229exp 3/31/23
- Amount recalled
- 30 count: 6 bottles; 90 count: 106 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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