Accord Healthcare recalls Daptomycin injections from specific batches manufactured by Intas Pharmaceuticals due to FDA inspection deviations. Consumers should check batch numbers and expiration dates to determine if their product is affected.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling Daptomycin injections that were manufactured by Intas Pharmaceuticals in India following an FDA inspection. The recall is due to compliance issues identified during the inspection, but no specific safety risks to patients have been reported.
The product was recalled because of compliance issues found during an FDA inspection. The hazard is related to manufacturing quality control, not a direct safety risk to patients during normal use.
Patients prescribed Daptomycin injections by a healthcare provider who received the recalled batches from Intas Pharmaceuticals in India. Those with the specific batch numbers listed in the recall are most at risk.
Check the batch numbers on the vial: R2101282 (exp. 9/30/2023), R2101600 (exp. 11/30/2024), and other specific batches listed in the recall. The product is a single-dose injection for prescription use only.
Look for the batch number on the vial label, which is listed in the recall (e.g., R2101282, R2101600).
The product was recalled due to compliance issues identified during an FDA inspection, not because of a safety risk to patients.
Check the batch number on the vial. If it matches the listed batches, contact your healthcare provider for further instructions.
The recall is due to manufacturing compliance issues, not a direct safety risk to patients during normal use.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0382-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0382-2023 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.
