Accord Healthcare is recalling Pravastatin Sodium Tablets 20mg (90-count) manufactured in India with specific batch numbers due to FDA inspection deviations. Consumers should check their product details and contact the company for instructions.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling Pravastatin Sodium Tablets 20mg (90-count) bottles made in India with specific batch numbers because an FDA inspection found manufacturing deviations. This recall is for prescription-only medication and does not involve immediate safety risks to users.
The recall is triggered by FDA inspection findings that identified manufacturing deviations in the production process. These deviations do not indicate immediate safety risks to users but require the product to be removed from circulation to ensure quality standards.
Prescription holders of Pravastatin Sodium Tablets 20mg (90-count) bottles with batch numbers R2200589, R2200689, R2200690, or R2201232 (expiring April 30, 2024) are affected. Patients taking this medication should check their product details.
Check for the product name 'Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle' with batch numbers R2200589, R2200689, R2200690, or R2201232, manufactured by Intas Pharmaceuticals Limited in India. The expiration date is April 30, 2024.
Identify the batch number and expiration date on your Pravastatin Sodium Tablets 20mg (90-count) bottle to confirm if it is in the recalled range.
The FDA found manufacturing deviations during an inspection, so the product is being recalled to ensure quality standards.
No, this recall does not pose an immediate safety risk. You should check your product details and contact Accord Healthcare if you have the recalled batch numbers.
Check the batch number on your bottle; if it is R2200589, R2200689, R2200690, or R2201232 with an expiration date of April 30, 2024, it is part of the recall.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0422-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0422-2023 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.
