Accord Healthcare recalls phenylephrine hydrochloride injection vials manufactured in India with FDA inspection deviations. This recall affects specific batches and expiration dates. Consumers should contact the manufacturer for details.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling phenylephrine hydrochloride injection vials that were made in India and shipped to the U.S. The recall follows an FDA inspection that found manufacturing quality issues. This means the product may not be safe for medical use.
The recall is due to FDA findings that the manufacturing process did not meet current Good Manufacturing Practices (CGMP). This means the product could be unsafe for medical use, but the exact risk level is not specified in the notice.
People who have the specific vial model with the listed batch numbers and expiration date of November 30, 2023, are affected. Healthcare providers using this product for medical treatments are most at risk.
Check for the vial label with 'Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial'. Look for the batch numbers R2101555, R2101538, or R2101564 and expiration date 11/30/2023.
Identify the vial's batch number and expiration date to confirm if it is part of the recall.
The FDA found manufacturing quality issues during an inspection, which means the product may not meet safety standards.
Contact Accord Healthcare directly for instructions on how to handle the recalled vials.
The recall notice does not specify the risk level, so it is unknown if there is a serious injury risk.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0401-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0401-2023 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.
