Reported Apr 5, 2023 · Terminated
Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; 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?
GlimepirideUSP4 mg TabletsRx OnlyPackaged as a a) 30-count bottleNDC 61919-0250-30b) 90-count bottleNDC 61919-0250-90
- Packaged and Distributed ByDirect Rx, Dawsonville, GA 30534
- Lot codes and dates
- a) [30 count bottles] Lot
- expiry
13DE2111exp 3/31/2024 b) [90 count bottles] Lot
- expiry
17NO2116exp 1/31/202427JA2234exp 4/30/202402MA2218exp 6/30/202412MY2211exp 7/31/202413JY2107exp 10/31/202315AP2221exp 7/31/202417AU2110exp 10/31/202320SE2108exp 10/31/202323JU2115exp 10/31/202328JY2101exp 10/31/202330JY2101exp 10/31/202305JA2212exp 3/31/202413DE2130exp 3/31/202421OC2111exp 1/31/202417NO2116exp 3/31/2024
- Amount recalled
- 30 count: 7 bottles; 90 count: 395 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Direct Rx recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.