Accord Healthcare recalls 100-count BusPIRone Hydrochloride Tablets 15mg (Rx only) manufactured in India following FDA inspection. Products may have CGMP deviations.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 100-count BusPIRone Hydrochloride Tablets 15mg (Rx only) because an FDA inspection found manufacturing quality issues. This recall affects prescription medication that may not meet safety standards.
The FDA identified manufacturing quality deviations during an inspection. This means the medication may not meet safety standards for prescription use, though the exact risk isn't specified in the recall notice.
Prescription patients who have received this specific medication from a pharmacy. Those with the NDC 16729-203-01 bottle are most at risk.
Check for the 100-count bottle labeled 'BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only'. The NDC code is 16729-203-01. Products were manufactured in India with batch numbers starting with P2105483.
Look for the NDC code 16729-203-01 on the bottle label to confirm if it's affected.
The FDA found manufacturing quality deviations during an inspection, which means the product may not meet safety standards.
Check for the NDC code 16729-203-01 on the bottle label. Products were manufactured in India with batch numbers starting with P2105483.
The recall notice does not specify a remedy or action for affected products.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0377-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0377-2023 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.
