Accord Healthcare recalls BusPIRone Hydrochloride Tablets 30mg 60-count bottles manufactured for FDA inspection deviations. No specific safety risks described in recall notice.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling BusPIRone Hydrochloride Tablets 30mg 60-count bottles due to FDA inspection findings. This recall does not specify any safety risks or hazards for consumers.
The recall is based on FDA inspection findings of CGMP (Current Good Manufacturing Practices) deviations. However, the official notice does not describe any specific safety risks or hazards that could affect consumers.
Prescription drug users who have the specific 30mg tablets with NDC 16729-289-12. Patients using these tablets for medical treatment are most at risk if they have the recalled batch.
Check for the 30mg tablets with NDC code 16729-289-12, manufactured by Intas Pharmaceuticals Limited in India. The recall includes specific batch numbers P2105551 with expiration date 7/31/2024.
Identify the NDC code 16729-289-12 and batch number P2105551 on the product label.
The recall is due to FDA inspection findings of CGMP deviations, but the official notice does not describe any specific safety risks for consumers.
The recall does not specify a remedy or action for consumers. Check the product details to see if it matches the recalled batch.
The official recall notice does not describe any specific safety risks or hazards that could cause injury.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0379-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0379-2023 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.
