Accord Healthcare recalls BusPIRone Hydrochloride 5mg tablets (NDC 16729-200-01 and 16729-200-16) after FDA inspection found manufacturing deviations. Consumers should check their product labels for batch numbers and expiration dates.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling BusPIRone Hydrochloride 5mg tablets due to FDA inspection findings indicating manufacturing deviations. This recall affects specific batches of the medication that were sold with certain product codes and expiration dates.
The recall is triggered by FDA inspections identifying manufacturing deviations in the production process. These deviations could potentially affect the safety and quality of the medication, though the exact nature of the deviations is not specified in the recall notice.
Prescription medication users who have the specific batch numbers listed in the recall notice. Patients with a prescription for BusPIRone Hydrochloride 5mg tablets are most at risk.
Check your BusPIRone Hydrochloride tablets for the product code NDC 16729-200-01 or 16729-200-16. Look for the batch number P2200530 (expiring 12/31/2024) or P2105583 (expiring 6/30/2024).
Look for the product code NDC 16720-200-01 or 16729-200-16 and batch numbers P2200530 or P2105583 on the packaging.
The FDA found manufacturing deviations during an inspection, which could affect the safety and quality of the medication.
Check your product labels for the specific batch numbers and expiration dates listed in the recall notice. If you have the recalled batch, contact Accord Healthcare for further instructions.
The recall notice does not specify the exact health risks, but the FDA found manufacturing deviations that could impact the medication's safety and quality.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0376-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0376-2023 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.
