Glenmark Pharmaceuticals recalls 80mg Pravastatin Sodium Tablets due to failed dissolution specifications. These tablets may not work as intended. Check NDC numbers and expiration dates for affected lots.
Failed Dissolution Specifications: results below specifications
Glenmark Pharmaceuticals is recalling 80mg Pravastatin Sodium Tablets that failed dissolution tests. This means the medication may not work properly in the body, potentially reducing effectiveness. Affected products were sold with specific NDC numbers and expiration dates.
The tablets failed to dissolve at the required rate, which could lead to reduced effectiveness. This means the medication might not work as intended to lower cholesterol levels. However, the risk is not immediate or life-threatening.
People prescribed this medication by a doctor who received the recalled tablets. Those taking the medication for cholesterol management are most at risk if the tablets don't dissolve properly.
Check for NDC numbers 68462-198-90 (90-count bottle) or 68462-198-05 (500-count bottle). The expiration dates range from June 30, 2024, to January 31, 2025, depending on the lot.
Look for the NDC numbers 68462-198-90 or 68462-198-05 on the bottle and expiration dates listed in the recall notice.
The recall is due to failed dissolution specifications, which may reduce effectiveness but is not immediately dangerous. The medication is still safe to take if prescribed by a doctor.
Check the NDC numbers 68462-198-90 (90-count bottle) or 68462-198-05 (500-count bottle) and the expiration dates listed in the recall notice.
No, the recall does not require stopping use. However, you should check if you have the recalled product and contact your doctor if you're unsure.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0612-2024 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0612-2024 from Glenmark. 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.
