Accord Healthcare recalls Daptomycin 350 mg/vial injections (NDC 16729-434-05) after FDA inspection found manufacturing deviations. This recall affects specific batches sold in the US.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling Daptomycin for Injection 350 mg/vial products due to manufacturing deviations found during an FDA inspection. This recall affects specific batches of the drug that were sold in the US. The recall is for prescription-only use only.
The FDA identified manufacturing deviations during an inspection of the drug product. These deviations could potentially affect the safety and quality of the medication, but the specific risk to patients is not detailed in the recall notice.
Prescription patients who have been prescribed Daptomycin for Injection 350 mg/vial. Healthcare providers who dispensed the recalled batches are most at risk.
Check the product label for the NDC code 16729-434-05 (single-dose vial) or 16729-434-45 (10 vials). The recall includes specific batch numbers with expiration dates from September 2023 to July 2025.
Look for the NDC code 16729-434-05 or 16729-434-45 on the vial packaging.
The FDA found manufacturing deviations during an inspection of the drug product.
Specific batches with expiration dates from September 2023 to July 2025, including R2101274 through R2201361.
The recall notice does not specify a remedy or action for consumers.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0381-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0381-2023 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.
