Accord Healthcare recalls BusPIRone Hydrochloride Tablets 7.5 mg 100-count bottles manufactured for FDA inspection deviations. No specific remedy stated in recall notice.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling BusPIRone Hydrochloride Tablets 7.5 mg 100-count bottles due to FDA inspection findings. This recall follows regulatory deviations in manufacturing processes, though no specific safety risk is described in the notice.
The recall is triggered by FDA inspection findings indicating manufacturing deviations. However, the recall notice does not specify what these deviations mean for patient safety or if they pose a risk of harm.
Prescription patients who received BusPIRone Hydrochloride Tablets 7.5 mg 100-count bottles manufactured by Intas Pharmaceuticals in India. Patients using these specific batches are most at risk.
Check for BusPIRone Hydrochloride Tablets 7.5 mg 100-count bottles with NDC 16729-201-01. Look for batch numbers P2105532 (expiring 6/30/2024) or P2200348 (expiring 12/31/2024).
Identify the NDC 16729-201-01, batch numbers P2105532 or P2200348, and expiration dates on the bottle.
The recall is due to FDA inspection findings indicating manufacturing deviations, but the specific safety risk is not described in the notice.
The recall notice does not specify a remedy, so no action is required beyond checking product details.
The recall notice does not describe any specific safety risks or hazards.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0375-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0375-2023 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.
