Accord Healthcare recalls specific batches of Succinylcholine Chloride Injection, USP, 200 mg/10 mL vials due to FDA inspection deviations. This medication is prescription-only and may pose risks if used without proper quality control.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling certain batches of Succinylcholine Chloride Injection, USP, 200 mg/10 mL vials because they were found to have manufacturing quality issues during an FDA inspection. This recall affects healthcare professionals who use the medication for medical procedures.
The recall is triggered by FDA findings that the drug products did not meet current Good Manufacturing Practices (CGMP) during an inspection. This means the medication may not be safe or effective when used as intended, though the specific risk to patients is not detailed in the recall notice.
Healthcare professionals who use this prescription-only medication for medical procedures are most at risk. Patients receiving the medication under a doctor's supervision are not directly affected by the recall.
Check for the vial label with 'Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL)' and the NDC code 16729-493-03. The recall includes specific batch numbers and expiration dates listed in the notice.
Identify the vial label with 'Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL)' and NDC 16729-493-03.
The recall is due to FDA inspection findings that the drug products did not meet current Good Manufacturing Practices (CGMP).
The recall notice does not specify a remedy, so contact Accord Healthcare directly for guidance.
Patients receiving the medication under a doctor's supervision are not directly affected by the recall.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0413-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0413-2023 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.
