Accord Healthcare recalls phenylephrine injection vials produced with FDA inspection deviations. This recall affects specific batches and requires immediate action to ensure safety.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling phenylephrine hydrochloride injection vials that were manufactured following an FDA inspection finding quality control deviations. This recall is necessary to prevent potential safety risks associated with the medication.
The recall is triggered by FDA inspections identifying manufacturing quality control deviations. These deviations could lead to unsafe medication if the product is used without proper quality assurance.
Prescription patients who received the recalled phenylephrine injection vials from specific batches and manufacturers. Healthcare providers using these vials for medical treatment are most at risk.
Check for the vial label with NDC 16729-465-31, UPC 3 16729 46531 1, or carton NDC 16729-465-03. The recall includes batches R2101570, R2101574, R2101576 expiring November 30, 2023.
Identify the vial by NDC 16729-465-31 or carton NDC 16729-465-03 to confirm if it is part of the recall.
The FDA identified manufacturing quality control deviations during an inspection, which could affect product safety.
Batches R2101570, R2101574, and R2101576 expiring November 30, 2023.
Look for the vial label with NDC 16729-465-31 or carton NDC 16729-465-03.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0402-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0402-2023 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.
