Accord Healthcare recalls 5mg rOPINIRole tablets from specific batches due to FDA inspection deviations. Consumers with these products should contact the manufacturer for details.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare has recalled 5mg rOPINIRole tablets from certain batches because of FDA inspection findings. This recall is for prescription-only products that may not meet quality standards.
The recall is due to FDA inspections finding deviations in current Good Manufacturing Practices (CGMP) for these tablets. This means the products may not meet quality standards, but the specific risk to consumers is not detailed in the recall notice.
Prescription holders of the recalled 5mg rOPINIRole tablets from specific batches and manufacturers. Individuals using these products without a prescription are not affected.
Check for the product name 'rOPINIRole Tablets USP 5 mg* 100-count bottle', prescription-only status, and batch numbers P2104150, P2104151, P2202065. The expiration dates are 6/30/2023 and 3/31/2024.
Identify the batch numbers (P2104150, P2104151, P2202065) and expiration dates (6/30/2023 or 3/31/2024) on the product label.
The FDA found deviations in current Good Manufacturing Practices (CGMP) during an inspection, which may affect product quality.
Look for the batch numbers P2104150, P2104151, or P2202065 and expiration dates of 6/30/2023 or 3/31/2024 on the product label.
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-0431-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0431-2023 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.
