Accord Healthcare recalls 10mg Montelukast Sodium Tablets (Rx only) manufactured for FDA compliance issues. Products with specific NDC and batch numbers are affected. Consumers should stop using and contact for details.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling Montelukast Sodium Tablets (10mg, Rx only) due to FDA inspection findings. This recall follows a CGMP deviation, meaning the product may not meet safety standards. Affected products have specific NDC and batch numbers listed in the recall notice.
The recall is triggered by FDA inspection findings indicating that the manufacturing process did not meet current Good Manufacturing Practices (CGMP). This means the product may not be safe for use as intended, though the specific risk to health is not detailed in the recall notice.
Prescription users of Montelukast Sodium Tablets (10mg) who purchased the recalled products with specific NDC and batch numbers. Patients with asthma or allergies to montelukast are at higher risk.
Check for the product's NDC number (16729-119-10, 16729-119-15, or 16729-119-17) and batch numbers listed in the recall notice. Products sold with specific expiration dates and packaging details are affected.
Identify the NDC number and batch numbers listed in the recall notice to confirm if your product is affected.
The product was recalled due to FDA inspection findings indicating a CGMP deviation, meaning the manufacturing process did not meet current Good Manufacturing Practices.
Check the NDC number and batch numbers listed in the recall notice to determine if your product is affected. If affected, stop using and contact Accord Healthcare for further instructions.
The recall notice states there is a CGMP deviation, but specific safety risks are not detailed. Consumers should follow the manufacturer's instructions for affected products.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0400-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0400-2023 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.
