Accord Healthcare recalls 4 mg Glimepiride Tablets USP (NDC 16729-003-01 and 16729-003-16) after FDA inspection found manufacturing deviations. Consumers should check product details and contact the manufacturer.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling certain Glimepiride Tablets USP 4 mg (Rx Only) due to FDA inspection finding manufacturing deviations. This recall affects people who have these specific product batches and may pose a risk of improper drug quality.
The FDA identified manufacturing deviations during an inspection, which could lead to improper drug quality. This means the medication might not be safe or effective for patients who need it.
People who have the recalled Glimepiride Tablets USP 4 mg (Rx Only) with the listed NDC numbers and batch codes are affected. Those with diabetes requiring this medication are most at risk.
Check for the NDC numbers 16729-003-01 (100-count bottle) or 16729-003-16 (500-count bottle) on the product label. Also look for the specific batch codes listed in the recall notice.
Identify the NDC number and batch code on your Glimepiride Tablets USP 4 mg product to confirm if it's recalled.
The FDA found manufacturing deviations during an inspection, which could affect the drug's safety and effectiveness.
Check the product details to see if it's in the recalled list. If it is, contact Accord Healthcare for further instructions.
The recall is due to manufacturing deviations, but the official notice does not specify a risk of serious injury or harm.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0395-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0395-2023 from Accord Healthcare. 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.
