Accord Healthcare recalls Finasteride Tablets 1 mg 90-count bottles manufactured for Thirty Madison, Inc. following FDA inspection for CGMP deviations. Consumers should check batch numbers and expiration dates.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling Finasteride Tablets 1 mg 90-count bottles that were manufactured for Thirty Madison, Inc. in New York. This recall follows FDA inspection findings that the products did not meet current good manufacturing practices (CGMP).
The recall is due to CGMP deviations found during an FDA inspection. This means the manufacturing process did not meet the required quality standards, potentially affecting product safety and effectiveness. However, the hazard does not involve immediate risks like injury or death.
Individuals who have the specific Finasteride Tablets 1 mg 90-count bottles with batch numbers listed in the recall notice are affected. Men prescribed finasteride for conditions like benign prostatic hyperplasia (BPH) are most at risk.
Check the product label for the batch numbers listed: P2005583, P2005584, P2005585, P2005527, P2005528, P2005586, P2005980, P2100396, P2100264, P2100263, P2101583, P2101711, P2101708, P2101584, P2102852, P2102851, P2102853, P2102854, P2102855, P2103993, P2103998, P2103997, P2103999, P2104205, P2104206, P2105631, P2105632, P2105546, P2105547, P2105548. Also check the expiration date on the label.
Look for the batch numbers listed in the recall notice and the expiration date on the product label.
The FDA found CGMP deviations during an inspection, meaning the manufacturing process did not meet quality standards.
Check the product label for the batch numbers listed in the recall notice. If you have the recalled batch, contact Accord Healthcare for instructions.
The recall is for quality control issues, not immediate safety risks like injury or death.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0391-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0391-2023 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.
