Glenmark Pharmaceuticals recalls 80mg Pravastatin Sodium Tablets due to CGMP deviations. Affected lots may have quality issues; contact for return instructions.
CGMP Deviations
Glenmark Pharmaceuticals is recalling 80mg Pravastatin Sodium Tablets (90-count) because of manufacturing quality control issues. This recall affects patients taking this medication as prescribed, though the specific risk is not detailed in the notice.
The recall is for CGMP (Current Good Manufacturing Practice) deviations, which means the tablets may not meet quality standards during production. This could lead to inconsistent medication strength or safety concerns, though the exact risk isn't specified in the notice.
Patients prescribed Pravastatin Sodium Tablets 80mg by a doctor are affected. Those using the medication as directed are most at risk due to potential quality issues.
Check for the product name 'Pravastatin Sodium Tablets 80mg, 90-count bottle' with the NDC code 68462-198-90. The affected lots have specific expiration dates listed in the recall notice.
Identify the product by checking the NDC code 68462-198-90 and lot numbers listed in the recall notice.
The recall is due to CGMP deviations, which means the manufacturing process may not have met quality standards. The exact risk is not specified in the notice.
Check for the NDC code 68462-198-90 and lot numbers listed in the recall notice, which include specific expiration dates.
The recall notice does not specify a remedy or action steps for affected products.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0325-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0325-2025 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.
