Direct Rx recalls 4mg Glimepiride tablets due to cGMP deviations. Affected lots expire by 3/31/2024. Consumers should check product details and contact manufacturer.
cGMP deviations
Direct Rx is recalling 4mg Glimepiride tablets that were manufactured with cGMP deviations. This means the tablets may not meet quality standards, though serious injury risks are not specified in the recall notice.
The recall is due to cGMP deviations, which are quality control issues in manufacturing. These deviations could mean the tablets do not meet the required standards for safety and effectiveness, but the recall does not specify a risk of serious injury or harm.
People who have the 30-count or 90-count bottles of Direct Rx Glimepiride 4mg tablets with the listed lot numbers and expiration dates are affected. Those taking this medication should check their specific product details.
Check for the product name 'Glimepiride, USP, 4 mg Tablets, Rx Only' with the lot numbers listed in the recall notice. The 30-count bottles have NDC 61919-0250-30 and expire by 3/31/2024, while the 90-count bottles have NDC 61919-0250-90 and expire by various dates through 2024.
Identify your specific bottle by checking the lot number and expiration date on the label.
The recall is for cGMP deviations, which means the tablets may not meet quality standards, but the notice does not specify a risk of serious injury or harm.
The recall does not provide specific action steps beyond checking your product details. Contact Direct Rx for further instructions.
Check the lot number and expiration date on the bottle. Affected products have specific lot numbers and expiration dates listed in the recall notice.
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0482-2023 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0482-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
