Accord Healthcare recalls rOPINIRole 4mg tablets (NDC 16729-237-01) manufactured in India following FDA inspection. Products may have CGMP deviations.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling rOPINIRole 4mg tablets after an FDA inspection found manufacturing quality issues. This recall affects prescription-only bottles with specific batch numbers and expiration dates.
The FDA identified manufacturing quality deviations during an inspection. This means the tablets may not meet safety and quality standards, though the exact risk level isn't specified in the recall notice.
Prescription holders of rOPINIRole 4mg tablets with batch numbers P2106136, P2106813, P2106814, or P2202764. Patients who have these specific batches are most at risk.
Check the bottle label for the product name 'rOPINIRole Tablets USP 4 mg* 100-count', NDC 16729-237-01, and batch numbers P2106136, P2106813, P2106814, or P2202764.
Identify the batch number and expiration date on the bottle label to confirm if it's part of the recalled products.
The FDA found manufacturing quality deviations during an inspection, so Accord Healthcare is recalling these tablets.
Batch numbers P2106136 (exp. 8/31/2023), P2106813 and P2106814 (exp. 9/30/2023), and P2202764 (exp. 4/30/2024).
The recall does not specify a stop-use instruction; check the product details to see if it's affected.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0430-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0430-2023 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.
