Glenmark Pharmaceuticals recalls 80mg Pravastatin Sodium Tablets due to CGMP deviations. Affected lots expire by August 2025. No specific remedy stated in recall notice.
CGMP Deviations
Glenmark Pharmaceuticals is recalling two types of 80mg Pravastatin Sodium Tablets because of manufacturing quality control issues. This recall affects patients who have these specific bottle sizes and expiration dates. The issue does not involve immediate safety risks but requires action to prevent potential medication errors.
CGMP deviations refer to manufacturing quality control failures that could lead to medication errors. These issues may result in incorrect dosages or impurities in the medication, though the exact risk is not specified in the recall notice.
Patients prescribed this medication by a healthcare provider are affected. Those with the specific bottle sizes and expiration dates listed in the recall are most at risk.
Check for bottles labeled 'Pravastatin Sodium Tablets, USP, 80mg' with either a 90-count bottle (NDC 16714-570-01) or 500-count bottle (NDC 16714-570-02). The expiration dates listed are August 2025 and May 2026.
Identify the bottle size and expiration date to confirm if your medication is affected by this recall.
The recall mentions CGMP deviations, which could lead to medication errors, but the specific risk level is not clearly stated in the notice.
The recall does not specify a remedy, so you should check the product details to see if it's affected and contact your healthcare provider for guidance.
Check for the specific bottle sizes and expiration dates listed in the recall notice: 90-count (NDC 16714-570-01) or 500-count (NDC 16714-570-02) with expiration dates up to August 2025 or May 2026.
We’ve drafted a message you can send Glenmark Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0350-2025 — Glenmark Pharmaceuticals Glenmark Pharmaceuticals Hello, I own a Glenmark Pharmaceuticals that is covered by recall D-0350-2025 from Glenmark 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.
