Accord Healthcare recalls 10mg Pravastatin tablets (NDC 16729-008-15 and 16729-008-16) after FDA inspection found manufacturing deviations. Consumers should check their bottles for batch numbers and expiration dates.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 10mg Pravastatin Sodium Tablets due to FDA inspection finding manufacturing deviations. This recall affects specific bottle sizes and batch numbers that may have quality issues.
The FDA found manufacturing deviations during an inspection, which means the tablets might not meet quality standards. This could affect the drug's safety and effectiveness, but the specific risk to consumers is not detailed in the recall notice.
People who have the recalled 90-count or 500-count bottles of Pravastatin Sodium Tablets (NDC 16729-008-15 or 16729-008-16) with batch numbers R2201093 or R2201222/R2201231. Those who take prescription statins for cholesterol management are most at risk.
Check your Pravastatin Sodium Tablets for the bottle label showing NDC 16729-008-15 (90-count) or NDC 16729-008-16 (500-count). Look for batch numbers R2201093 or R2201222/R2201231 with an expiration date of 4/30/2024.
Identify your bottle's NDC number and batch number to confirm if it's part of the recall.
Talk to your doctor or pharmacist about whether you need to stop taking the medication or get a replacement.
The FDA found manufacturing deviations during an inspection, which means the product may not meet quality standards.
Check your bottle's NDC number and batch number. Contact your healthcare provider for guidance on next steps.
The recall notice does not specify a risk of serious injury; it only mentions manufacturing deviations.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0421-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0421-2023 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.
