Accord Healthcare recalls 25 vials of Glycopyrrolate Injection due to FDA inspection finding CGMP deviations. This medication is prescription-only and may be unsafe if used after the recall date.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 25 vials of Glycopyrrolate Injection (0.2 mg/mL, 1 mL single dose) because an FDA inspection found manufacturing quality control issues. This recall affects prescription-only medication that could be unsafe if used after the recall date.
The FDA identified manufacturing quality control deviations during an inspection. This means the product may not meet safety and quality standards, potentially causing harm if used improperly. However, the exact nature of the deviation is not specified in the recall notice.
Prescription patients who received this specific Glycopyrrolate Injection product from Accord Healthcare. Healthcare providers using the medication in clinical settings are most at risk due to potential safety issues.
Check for the product name 'Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials' with NDC 16729-471-63 or 16729-471-08. The product was manufactured by Intas Pharmaceuticals in India and distributed by Accord Healthcare in the US.
Verify the NDC codes 16729-471-63 (vials) or 16729-471-08 (carton) to confirm if you have the recalled product.
The FDA found manufacturing quality control deviations during an inspection, which means the product may not meet safety and quality standards.
The recall notice does not specify a remedy, so contact Accord Healthcare directly for guidance on next steps.
The recall indicates potential safety issues, but the exact risk is not specified in the notice.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0396-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0396-2023 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.
