Accord Healthcare recalls rOPINIRole 0.5mg tablets manufactured for FDA inspection deviations. Products with specific batch numbers and expiration dates are affected. Consumers should contact the manufacturer for details.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling rOPINIRole 0.5mg tablets due to FDA inspection findings that indicate manufacturing quality control issues. This recall affects specific batches of the medication that were produced for prescription use.
The recall is triggered by FDA inspections identifying deviations in current good manufacturing practices (CGMP). This means the medication may not meet the required quality standards, potentially affecting safety and effectiveness.
Prescription patients who have the specific batch numbers listed in the recall notice. Those using the medication for medical purposes are most at risk due to potential quality control issues.
Check the product label for the batch numbers listed: P2102133, P2102135, P2102136, P2104998, P2104997, P2104991, P2104992, P2104990, P2104993, P2105000, P2105002, P2105001, P2200433, P2200434, P2200435, P2202730, P2202729, P2203517. The product is a prescription-only medication with specific expiration dates.
Look for the batch numbers listed in the recall notice to determine if your medication is affected.
Reach out to Accord Healthcare for further instructions on what to do with the affected product.
The FDA identified manufacturing quality control issues during an inspection, which may affect the medication's safety and effectiveness.
Check the product label for the specific batch numbers listed in the recall notice and contact Accord Healthcare for further instructions.
The recall is due to potential quality control issues, but the specific safety risks are not detailed in the official notice.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0426-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0426-2023 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.
