Accord Healthcare recalls Daptomycin 350mg vials that mistakenly contain 500mg per vial. This labeling error could lead to incorrect dosing. Affected vials have NDC 16729-0434-05 and lot R2200232.
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Accord Healthcare is recalling Daptomycin 350 mg/vial injections because some vials contain 500 mg instead of 350 mg due to a labeling mixup. This error could cause incorrect dosing if used without checking the actual contents.
The vials are labeled as 350 mg but contain 500 mg due to a manufacturing labeling error. This could lead to incorrect dosing if the vial is used without checking the actual contents. The risk is low because the error is a labeling mixup, not a safety issue with the product itself.
Prescribers and patients who received Daptomycin 350 mg/vial injections with NDC 16729-0434-05 and lot R2200232. Those using the product without verifying the actual contents are at risk of incorrect dosing.
Check for vials labeled 'Daptomycin 350 mg/vial' with NDC 16729-0434-05 and lot number R2200232. These vials were manufactured by Intas Pharmaceuticals Limited in India and distributed by Accord Healthcare in the U.S.
Verify the actual contents of the vial by checking the label for the correct dosage (350 mg) before use.
The recall was issued because vials labeled as 350 mg contain 500 mg due to a labeling mixup during manufacturing.
Look for vials with NDC 16729-0434-05 and lot number R2200232, manufactured by Intas Pharmaceuticals Limited in India.
No, but you should check the actual contents before use to avoid incorrect dosing.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0131-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0131-2023 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.
