Accord Healthcare is recalling 10mg Aripiprazole tablets (NDC 16729-280-10 and 16729-280-01) after FDA inspection found manufacturing deviations. Consumers should check product details and contact the company for instructions.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 10mg Aripiprazole tablets from specific batches due to FDA inspection finding manufacturing deviations. This recall means the medication may not be safe for use as intended.
The FDA found manufacturing deviations during an inspection, which means the tablets may not meet quality standards. This could affect the medication's safety and effectiveness, but the exact risk level isn't specified in the recall notice.
People who have the recalled 10mg Aripiprazole tablets (NDC 16729-280-10 or 16729-280-01) from specific batches. Those taking this medication for mental health conditions are most at risk.
Check the product label for the NDC code 16729-280-10 (30-count bottle) or 16729-280-01 (100-count bottle). Also look for batch numbers like P2006421 or P2102144 on the packaging.
Look for the NDC code 16729-280-10 or 16729-280-01 on the bottle label.
The FDA found manufacturing deviations during an inspection, which means the tablets may not meet quality standards.
The recall notice does not specify a remedy, so contact Accord Healthcare directly for instructions.
Yes, specific batches like P2006421, P2102144, and others are listed in the recall 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-0367-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0367-2023 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.
