Accord Healthcare recalls rOPINIRole 0.25mg tablets (NDC 16729-232-01) manufactured in India following FDA inspection. Products may have CGMP deviations affecting safety.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling rOPINIRole 0.25mg tablets due to FDA inspection finding manufacturing deviations. This recall affects specific batches produced in India and sold with certain expiration dates. The recall is necessary to ensure product safety as per FDA standards.
The recall is triggered by FDA inspections identifying CGMP (Current Good Manufacturing Practices) deviations during production. These deviations could potentially affect the safety and quality of the medication, though the exact nature of the issues isn't specified in the recall notice.
Prescription owners of rOPINIRole 0.25mg tablets with the specified batch numbers and expiration dates are affected. Patients using these tablets for medical purposes are most at risk due to potential manufacturing issues.
Check for the product name 'rOPINIRole Tablets USP 0.25 mg', 100-count bottle, and prescription-only status. Look for batch numbers like P2102086 through P2203516 with corresponding expiration dates.
Verify the batch number and expiration date on the product label to confirm if it's part of the recalled batches.
The FDA identified manufacturing deviations during an inspection, which could affect product safety. The exact nature of the deviations isn't specified in the recall notice.
Check the batch number and expiration date on the product label. Recalled batches include specific numbers like P2102086 through P2203516 with corresponding expiration dates.
The recall notice does not specify a remedy or action for affected products. You should 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-0425-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0425-2023 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.
