Direct Rx recalls 2mg Glimepiride tablets due to cGMP deviations. Affected lots expire 9/30/2023 to 4/30/2024. Check your bottle's NDC and lot number.
cGMP deviations
Direct Rx is recalling 2mg Glimepiride tablets that were made with cGMP deviations. This means the tablets might not be safe or effective as intended. If you have these tablets, you should check if they're in the recalled lots.
The recall is due to cGMP deviations, which are quality control issues in manufacturing. This could mean the tablets might not be safe or effective. However, the exact risk isn't specified in the recall notice.
People who have the recalled 2mg Glimepiride tablets from Direct Rx, including those with diabetes prescriptions. Those with diabetes who take this medication are most at risk.
Check for Direct Rx 2mg Glimepiride tablets with NDC numbers 61919-0488-30 (30-count) or 61919-0448-90 (90-count). Look for specific lot numbers listed in the recall notice, such as 21JU2112 through 21OC2115.
Look for the NDC number on the bottle and compare it to the listed NDCs: 61919-0488-30 or 61919-0448-90.
The recall is due to cGMP deviations, which are quality control issues in manufacturing. The exact risk isn't specified in the recall notice.
Check if your tablets are in the recalled lots by looking at the NDC and lot numbers. If they are, contact Direct Rx for further instructions.
The recall notice states there were cGMP deviations, but it does not specify if there are safety risks or how serious they are.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0481-2023 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0481-2023 from Direct Rx. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
