Accord Healthcare recalls 25-vial Glycopyrrolate Injection due to FDA inspection finding manufacturing deviations. This medication is prescription-only and may be unsafe if used as intended.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 25-vial packages of Glycopyrrolate Injection (0.4 mg/2 mL) because an FDA inspection found manufacturing deviations. This recall affects prescription-only medication that could be unsafe if used as intended.
The FDA identified manufacturing deviations during an inspection. This means the medication may not be produced safely or consistently, potentially affecting its effectiveness or safety.
Prescription patients using Glycopyrrolate Injection for medical purposes. Healthcare providers who dispense this medication are most at risk.
Check for 25 vials of Glycopyrrolate Injection (0.4 mg/2 mL) with NDC 16729-472-30 or carton NDC 16729-472-08. The product was manufactured in batches R2200507, R2200508, or R2200509 and expires April 30, 2024.
Verify the product's NDC code (16729-472-30) and carton NDC (16729-472-08) to confirm it is part of this recall.
The recall is due to FDA inspection finding manufacturing deviations, so the medication may not be produced safely or consistently. Do not use until the recall is resolved.
The recall does not specify a remedy, so contact Accord Healthcare directly for guidance on next steps.
Check the NDC code (16729-472-30) and carton NDC (16729-472-08) on the product label. The product was manufactured in batches R2200507, R2200508, or R2200509 and expires April 30, 2024.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0397-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0397-2023 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.
