Preferred Pharmaceuticals is recalling 2 mg Glimepiride Tablets (NDC 68788-8095-9) manufactured by Accord Healthcare due to cGMP deviations. This recall follows inspection findings and affects specific lots with expiration dates through June 2024.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Preferred Pharmaceuticals is recalling 2 mg Glimepiride Tablets (Rx only) that were manufactured by Accord Healthcare. The recall is due to manufacturing quality issues found during inspections, which could affect product safety.
The recall is based on cGMP (current Good Manufacturing Practice) deviations found during inspections at Accord Healthcare's manufacturing facility. This means the tablets may not meet quality standards, potentially affecting safety and effectiveness, but the exact risk is not specified in the recall notice.
People with prescriptions for Glimepiride Tablets (2 mg) from the specific lots listed in the recall. Those using the medication for diabetes management are most at risk if they have the recalled product.
Check the product label for the NDC number 68788-8095-9, lot numbers D0122K (exp. 6/30/2024), I1422N (exp. 9/30/2024), or I2721B (exp. 1/31/2024), and expiration dates listed above. The product is prescription-only and sold in 90-count bottles.
Look for the NDC number 68788-8095-9 and specific lot numbers D0122K, I1422N, or I2721B on the bottle.
The recall is due to cGMP deviations found during inspections at Accord Healthcare's manufacturing facility, which may affect product quality and safety.
The recall notice does not specify a remedy or action for affected products. Check the product label for the NDC number and lot numbers to confirm if it's recalled.
The recall notice does not specify the exact safety risks. The hazard is described as cGMP deviations, which could affect product safety but the exact risk is not detailed.
We’ve drafted a message you can send Preferred Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0517-2023 — Preferred Pharmaceuticals Preferred Pharmaceuticals Hello, I own a Preferred Pharmaceuticals that is covered by recall D-0517-2023 from Preferred Pharmaceuticals. 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.