Accord Healthcare is recalling 30-count and 100-count Aripiprazole 5mg tablets (NDC 16729-279-10 and 16729-279-01) 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 specific batches of Aripiprazole 5mg tablets due to manufacturing deviations found during an FDA inspection. This recall affects consumers who have these particular bottle sizes and batch numbers, though the recall does not pose an immediate safety risk to users.
The recall was initiated because the FDA identified manufacturing deviations during an inspection of the drug production process. These deviations could potentially affect the quality and safety of the medication, but the recall does not indicate an immediate risk of serious injury or harm to users.
People who have the recalled 30-count or 100-count Aripiprazole 5mg tablets with specific batch numbers and expiration dates listed in the recall notice. Those most at risk are individuals using these medications who may have the affected batches.
Check if your Aripiprazole 5mg tablets are in a 30-count bottle (NDC 16729-279-10) or 100-count bottle (NDC 16729-279-01). Look for batch numbers starting with P2004259 through P2204239 and expiration dates listed in the recall notice.
Identify if your Aripiprazole 5mg tablets match the recalled batch numbers and expiration dates listed in the recall notice.
Reach out to Accord Healthcare for specific instructions on what to do with the recalled medication.
The FDA found manufacturing deviations during an inspection of the drug production process, which could affect the quality and safety of the medication.
The recall does not require stopping use immediately; however, you should check if your medication is affected and contact Accord Healthcare for guidance.
Affected batch numbers range from P2004259 to P2204239 with specific expiration dates 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-0366-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0366-2023 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.
