Accord Healthcare recalls 10-vial Glycopyrrolate injection due to FDA inspection finding CGMP deviations. This medication is prescription-only and may pose safety risks if used without proper manufacturing standards.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 10-vial packages of Glycopyrrolate injection (1 mg/5 mL) because an FDA inspection found manufacturing quality issues. This recall affects prescription-only medication that could be unsafe if not produced correctly.
The FDA identified manufacturing quality deviations during an inspection. This means the product may not meet safety and quality standards, potentially leading to unsafe medication if used without proper quality control.
Prescription patients who have received this specific Glycopyrrolate injection product from Accord Healthcare. Healthcare providers using the medication are most at risk due to potential quality issues.
Check for the 10-vial carton labeled 'Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial'. The product has specific batch numbers and expiration dates listed in the recall notice.
Look for the carton NDC 16729-473-03 or batch numbers R2200259, R2200258, R2200617, or R2201308 on the vial packaging.
The recall indicates FDA found manufacturing quality issues, so the product may not be safe. Do not use until the recall is resolved.
Check for the specific batch numbers (R2200259, R2200258, R2200617, R2201308) and expiration dates listed in the recall notice.
The recall does not specify a remedy, so contact Accord Healthcare directly for guidance on next steps.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0398-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0398-2023 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.
