Accord Healthcare is recalling 20 mg Aripiprazole tablets from specific batches after FDA inspection found manufacturing deviations. Consumers should check product details and contact the company for guidance.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 20 mg Aripiprazole tablets from certain batches due to FDA inspection finding manufacturing deviations. This recall affects patients who may have been prescribed these tablets and requires them to check their product details and contact the company.
The recall is due to FDA inspections finding manufacturing deviations in the production process. This means the tablets may not meet quality standards and could be unsafe for use, though the exact risk is not specified in the recall notice.
Patients prescribed 20 mg Aripiprazole tablets by a healthcare provider. Those with the specific batch numbers and expiration dates listed in the recall are most at risk.
Check for the 30-count bottle with NDC 16729-282-10 or UPC 3 16729 28210 9, or the 100-count bottle with NDC 16729-282-01 or UPC 3 16729 28201 7. The recall includes specific batch numbers and expiration dates listed in the notice.
Identify the product by checking the NDC number, UPC code, and batch numbers listed in the recall notice.
The FDA found manufacturing deviations during an inspection, which means the product may not meet quality standards.
Check the product details against the recall list and contact Accord Healthcare for further guidance.
The recall is due to manufacturing deviations, but the specific safety risks are not detailed in the official notice.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0369-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0369-2023 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.
