Accord Healthcare recalls 100-count and 1,000-count Doxazosin 4mg tablets (NDC 16729-213-01 and 16729-213-17) 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 Doxazosin 4mg tablets after an FDA inspection found manufacturing quality control issues. This recall affects specific packaging batches that may contain unsafe levels of the drug.
The FDA identified manufacturing quality control deviations during an inspection. This means the tablets may not meet safety standards, potentially leading to inconsistent drug strength or impurities. However, the exact health risk is not specified in the recall notice.
People who have the recalled Doxazosin 4mg tablets (100-count or 1,000-count bottles) with the listed NDC numbers and batch dates. Those using the medication for blood pressure treatment are most at risk.
Check the product label for NDC 16729-213-01 (100-count bottle) or NDC 16729-213-17 (1,000-count bottle). Look for batch numbers like R2200352 through R2200646 and expiration dates listed in the recall notice.
Look for the NDC number 16729-213-01 or 16729-213-17 on the bottle to confirm it's part of the recall.
Check the batch number on the label, which should match the listed batches (R2200352 to R2200646) for the specific expiration date.
The FDA found manufacturing quality control deviations during an inspection, which may affect the safety and consistency of the drug.
The recall notice does not specify a remedy, so contact Accord Healthcare directly for guidance on next steps.
Yes, the recalled batches have expiration dates from April 30, 2025, to May 31, 2024, but the exact date depends on the batch number.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0388-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0388-2023 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.
