Accord Healthcare recalls 4 mg/20 mL Glycopyrrolate Injection due to FDA inspection finding CGMP deviations. Products may be unsafe for medical use. Check NDC codes and batch numbers for affected items.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling a specific glycopyrrolate injection product due to FDA inspection finding quality control issues. This recall affects medical users who may have this medication, as it could pose safety risks if used improperly.
The FDA identified quality control deviations during manufacturing. This means the medication might not meet safety standards, potentially causing harm if used incorrectly or inappropriately.
Healthcare providers and patients prescribed this medication by a doctor. Those using the product for medical purposes are most at risk due to potential quality control issues.
Check for NDC code 16729-474-05 on the vial and NDC 16729-474-03 on the carton. Products with batch numbers R2200431 (expiring 7/31/2023) or R2200439 (expiring 9/30/2023) are affected.
Look for NDC codes 16729-474-05 and 16729-474-03 on the vial and carton, respectively.
The FDA found quality control deviations during manufacturing, which could affect the medication's safety.
Check for NDC code 16729-474-05 on the vial and NDC 16729-474-03 on the carton. Affected batches are R2200431 (expiring 7/31/2023) or R2200439 (expiring 9/30/2023).
The recall record 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-0399-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0399-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
