Accord Healthcare recalls 2.5mg Tadalafil Tablets from specific batches due to FDA inspection deviations. Consumers should check product labels for NDC codes and batch numbers to determine if affected.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 2.5mg Tadalafil Tablets that were manufactured following FDA inspection findings. This recall is due to potential quality control issues identified during the inspection process.
The recall is triggered by FDA inspections finding deviations in current good manufacturing practices (CGMP). This means the medication may not meet quality standards, though the exact risk to consumers is not specified in the recall notice.
People who have the specific 30-count or 500-count bottles of Tadalafil Tablets with the listed NDC and UPC numbers are affected. Those using the medication for erectile dysfunction may be at risk if they have the recalled batches.
Check the product label for the NDC code 16729-369-10 (30-count bottle) or 16729-369-16 (500-count bottle) and the UPC code 3 16729 36910 7 or 3 16729 36916 9. Also look for batch numbers and expiration dates listed in the description.
Look for the NDC code 16729-369-10 or 16729-369-16 and the corresponding UPC code on the packaging.
The FDA identified deviations in current good manufacturing practices during an inspection, which may affect the quality of the medication.
The recall notice does not specify a remedy, so contact Accord Healthcare directly for further instructions.
Yes, the recall includes specific batch numbers like P2002522 (expiring 4/30/2023) and others listed in the product description.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0414-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0414-2023 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.
