Accord Healthcare recalls 100-count rOPINIRole 2mg tablets (NDC 16729-235-01) manufactured for FDA inspection deviations. Consumers should check batch numbers and expiration dates for affected products.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare has recalled 100-count rOPINIRole 2mg tablets due to FDA inspection findings. This recall affects prescription-only products with specific batch numbers and expiration dates. The recall is necessary to address potential quality issues identified during regulatory inspections.
The recall is triggered by FDA inspections identifying manufacturing quality deviations. These deviations could affect the safety and efficacy of the medication, though the specific risks are not detailed in the notice.
Prescription holders of rOPINIRole 2mg tablets with batch numbers P2106370, P2106369, or P2201254. Patients using these specific batches are most at risk due to the FDA inspection findings.
Check the product label for batch numbers P2106370, P2106369, or P2201254. The expiration date for these batches ranges from 9/30/2023 to 2/29/2024. The product is a prescription-only 100-count bottle with NDC 16729-235-01.
Review the batch number and expiration date on the product label to confirm if it matches the affected batches.
The FDA identified manufacturing quality deviations during an inspection, which prompted this recall.
Check the batch numbers on the label: P2106370, P2106369, or P2201254, with expiration dates from 9/30/2023 to 2/29/2024.
The recall does not specify a stop-use instruction; check the product details to confirm if it is 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-0428-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0428-2023 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.
