Reported Apr 5, 2023 · Terminated
Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; 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?
GlimepirideUSP2 mg TabletsRx OnlyPackaged as a a) 30-count bottleNDC 61919-0488-30b) 90-count bottleNDC 61919-0448-90
- Packaged and Distributed ByDirect Rx, Dawsonville, GA 30534
- Lot codes and dates
- a) [30 count bottles] Lot
- expiry
21JU2112exp 9/30/2023 b) [90 count bottles] Lot
- expiry
22DE2113exp 1/31/202427JA2235exp 3/31/202405AP2224exp 7/31/202406AU2104exp 1/31/202408JU2215exp 9/30/2024209AU2109exp 1/31/202415JU2113exp 9/30/202321FE2217exp 4/30/202421OC2115exp 2/29/202423JY2144exp 1/31/202425JU2124exp 9/30/202329AP2219exp 7/31/202407DE2128exp 3/31/2024
- Amount recalled
- 30 count: 12 bottles; 90 count: 253 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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