Accord Healthcare is recalling 5mg Rosuvastatin tablets (NDC 16729-284-15 and 16729-284-17) after FDA inspection found manufacturing deviations. Consumers should check their bottles for specific batch numbers and expiration dates.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 5mg Rosuvastatin tablets due to manufacturing deviations found during an FDA inspection. This recall affects specific batch numbers and expiration dates of the medication. The recall is necessary to ensure product safety and compliance with FDA standards.
The FDA identified manufacturing deviations in the production process for these tablets. This means the medication may not meet quality and safety standards, potentially leading to ineffective treatment or other health risks. However, the exact nature of the deviations and their impact on safety are not specified in the recall notice.
People who have the recalled 5mg Rosuvastatin tablets with specific batch numbers and expiration dates listed in the recall notice. Those taking this medication for cholesterol management are most at risk if they have the affected batches.
Check your Rosuvastatin tablets for the NDC codes 16729-284-15 (90-count bottle) or 16729-284-17 (1,000-count bottle). Look for batch numbers like P2101063, P2101707, or others listed in the recall notice with specific expiration dates.
Identify your tablet batch number and expiration date to confirm if it's in the recalled list.
The FDA found manufacturing deviations during an inspection, which means the tablets may not meet quality and safety standards.
The recall notice does not specify a stop-use instruction, but you should check if your batch is affected before continuing use.
Check the NDC codes and batch numbers listed in the recall notice to see if your tablets match the affected batches.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0404-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0404-2023 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.
