Accord Healthcare is recalling phenylephrine hydrochloride injection vials produced in India with potential CGMP deviations found during FDA inspection. This is a prescription-only medication.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling phenylephrine hydrochloride injection vials that were manufactured in India and distributed in the US. The recall follows FDA inspection findings that the products did not meet current good manufacturing practices (CGMP). This affects patients who have been prescribed this medication.
The FDA identified manufacturing process deviations during an inspection that could affect product quality. This means the medication might not be safe or effective as intended. However, the specific risk to patients is not detailed in the recall notice.
Prescription patients who received phenylephrine hydrochloride injection vials with NDC 16729-466-03, manufactured in batches R2101590-R2101599 and expiring November 30, 2023. Healthcare providers who dispensed these vials are also affected.
Check for the NDC code 16729-466-03 on the vial label. The vials were manufactured in batches R2101590 through R2101599 and expire November 30, 2023. They were produced by Intas Pharmaceuticals in India and distributed by Accord Healthcare.
Look for the NDC code 16729-466-03 and batch numbers R2101590-R2101599 on the vial.
The recall states that FDA found CGMP deviations during inspection, but does not specify if the medication is unsafe. Patients should follow the recall instructions.
Check the vial label for NDC 16729-466-03, batch numbers R2101590-R2101599, and expiration date November 30, 2023.
The recall does not specify a remedy, so contact your healthcare provider or pharmacist for guidance.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0403-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0403-2023 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.
