Accord Healthcare is recalling 15mg Aripiprazole tablets from specific batches manufactured in India due to FDA inspection deviations. Consumers should check product labels for NDC codes and batch numbers to determine if affected.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 15mg Aripiprazole tablets that were made in India and shipped to the U.S. because an FDA inspection found quality control issues. This recall affects specific batches with certain expiration dates and packaging details.
The FDA found quality control deviations during an inspection of the manufacturing process. This means the tablets might not meet safety and effectiveness standards, but the exact risk to patients isn't specified in the recall notice.
People who have the 15mg Aripiprazole tablets with the listed NDC codes and batch numbers are affected. Those taking this medication for mental health conditions are most at risk if they use the recalled products.
Check the product label for the NDC code 16729-281-10 (30-count bottle) or 16729-281-01 (100-count bottle). Also look for batch numbers like P2004997 through P2207240 with specific expiration dates.
Look for the NDC code on the bottle label to confirm if it matches the recalled products.
The FDA found quality control deviations during an inspection of the manufacturing process.
The recall notice does not specify a remedy or action for consumers.
Yes, specific batches with NDC codes 16729-281-10 and 16729-281-01 and batch numbers like P2004997 through P2207240 are affected.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0368-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0368-2023 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.
