Accord Healthcare recalls rOPINIRole 3mg tablets (NDC 16729-236-01) manufactured in India with FDA inspection deviations. Consumers with these specific batches should contact the company for details.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling rOPINIRole 3mg tablets due to FDA inspection findings indicating manufacturing quality control issues. This recall affects specific batches of tablets sold in the U.S. with a prescription requirement.
The recall is based on FDA inspections finding deviations in current good manufacturing practices (CGMP). This means the tablets may not meet safety and quality standards, though the exact nature of the deviations isn't specified in the notice.
Prescription holders of the rOPINIRole 3mg tablets with the specific batch numbers listed in the recall notice. Patients using these tablets are most at risk if they have the affected batches.
Check the product label for the batch numbers: P2105099, P2105098, P2106507, P2106508, P2106510, P2106509, or P2202750. The expiration dates are 7/31/2023, 9/30/2023, or 4/30/2024.
Look for the batch numbers listed in the recall notice: P2105099, P2105098, P2106507, P2106508, P2106510, P2106509, or P2202750.
The FDA found manufacturing quality control deviations during an inspection, which means the product may not meet safety and quality standards.
The recall notice does not specify a remedy, so contact Accord Healthcare directly for instructions.
The recall indicates potential quality issues, but the exact risk is not specified in the 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-0429-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0429-2023 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.
