Accord Healthcare recalls Rosuvastatin 40mg tablets (NDC 16729-287-10, etc.) after FDA inspection found manufacturing deviations. Consumers should contact the manufacturer for details.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling Rosuvastatin 40mg tablets that were manufactured in batches with potential quality control issues. This recall follows an FDA inspection that found deviations in the manufacturing process, which could affect the safety and effectiveness of the medication.
The recall is triggered by FDA inspections identifying manufacturing deviations in the production of these statin tablets. These deviations could potentially impact the quality and safety of the medication, though the exact risk to consumers is not specified in the recall notice.
Prescription holders of Rosuvastatin 40mg tablets with the specific NDC numbers listed in the recall notice are affected. Patients who have these medications should check their packaging for the batch numbers and expiration dates.
Check the product packaging for the NDC numbers: 16729-287-10 (30-count), 16729-287-15 (90-count), or 16729-287-17 (1,000-count). Also look for the batch numbers and expiration dates listed in the recall notice.
Look for the NDC numbers and batch information on the packaging to confirm if your medication is part of the recall.
Reach out to Accord Healthcare for further instructions on what to do with the recalled medication.
The recall is due to FDA inspections finding manufacturing deviations in the production of these statin tablets.
Check the product packaging for the NDC numbers and batch information. Contact Accord Healthcare for specific instructions.
The recall notice states that manufacturing deviations could affect the safety and effectiveness of the medication, but specific health risks are not detailed.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0407-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0407-2023 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.
