Accord Healthcare is recalling 2mg Aripiprazole tablets (NDC 16729-278-10 and 16729-278-01) 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 2mg Aripiprazole tablets due to FDA inspection finding manufacturing deviations. This recall affects specific packaging and batch numbers. The recall is necessary to ensure product safety as per FDA standards.
The FDA identified manufacturing deviations during an inspection, which could mean the tablets may not meet quality and safety standards. This affects the product's reliability and safety for patients taking it as prescribed.
Prescription patients who have the specific 2mg Aripiprazole tablets with the listed NDC numbers and batch codes are affected. Those using the medication as prescribed are most at risk if the product was manufactured with deviations.
Check for the 30-count bottle (NDC 16729-278-10) or 100-count bottle (NDC 16729-278-01) with the listed batch numbers and expiration dates. The product is manufactured by Intas Pharmaceuticals in India.
Identify the NDC number and batch code on the packaging to confirm if your tablets are part of the recall.
Reach out to Accord Healthcare directly for specific instructions on what to do with the recalled product.
The FDA found manufacturing deviations during an inspection, which means the product may not meet quality and safety standards.
Contact Accord Healthcare directly for instructions on how to handle the recalled product.
Yes, check the batch numbers listed in the recall notice, such as P2005474 through P2203334 with specific expiration dates.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0365-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0365-2023 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.
