Accord Healthcare recalls rOPINIRole 1mg tablets (NDC 16729-234-01) manufactured in India with FDA inspection deviations. Consumers should check batch numbers and expiration dates for affected lots.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare has recalled rOPINIRole 1mg tablets due to FDA inspection findings indicating manufacturing deviations. This recall affects specific batches produced in India with expiration dates up to May 2024. The recall is necessary to ensure product safety as per FDA standards.
The recall is triggered by FDA inspections finding manufacturing deviations in the production process. These deviations could potentially compromise the safety and quality of the medication. The exact nature of the deviations is not specified in the recall notice.
Prescription holders of rOPINIRole 1mg tablets with batch numbers P2103544 through P2203543 are affected. Individuals using these tablets for medical purposes are at risk if they have the recalled batches.
Check the batch number on the tablet packaging, which ranges from P2103544 to P2203543. The expiration dates for these batches are May 31, 2023 through May 31, 2024.
Look for the batch number on the tablet packaging, which should be between P2103544 and P2203543.
The FDA found manufacturing deviations during an inspection, which could affect product safety and quality.
Check the batch number on the packaging, which ranges from P2103544 to P2203543. The expiration dates for these batches are May 31, 2023 through May 31, 2024.
The recall notice does not specify a remedy, so contact Accord Healthcare directly for further instructions.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0427-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0427-2023 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.
