Preferred Pharmaceuticals recalls Montelukast Sodium Tablets (10mg) with NDC codes 68788-9438-3, 68788-9438-6, and 68788-9438-9 due to manufacturing deviations found by Accord Healthcare during inspections.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Preferred Pharmaceuticals is recalling Montelukast Sodium Tablets (10mg) because manufacturing deviations were found at Accord Healthcare during inspections. This recall affects specific packaging sizes and expiration dates, but no injuries have been reported.
The recall is due to manufacturing deviations identified at Accord Healthcare during inspections. These deviations could potentially affect the safety and quality of the medication, though no injuries have been reported.
People who have the recalled Montelukast Sodium Tablets (10mg) in 30-count, 60-count, or 90-count bottles with specific NDC codes and expiration dates are affected. Those using the medication for asthma or allergies are most at risk.
Check for Montelukast Sodium Tablets (10mg) in 30-count, 60-count, or 90-count bottles with NDC codes 68788-9438-3, 68788-9438-6, or 68788-9438-9. The products were manufactured by Accord Healthcare in Durham, NC and have specific expiration dates.
Identify the NDC code and expiration date on the bottle to confirm if it is part of the recalled batch.
The recall is due to manufacturing deviations found at Accord Healthcare during inspections, which could affect the safety and quality of the medication.
The affected products are Montelukast Sodium Tablets (10mg) in 30-count (NDC 68788-9438-3), 60-count (NDC 68788-9438-6), and 90-count (NDC 68788-9438-9) bottles.
The recall does not specify a stop-use instruction, so you should check the product details to confirm if it is recalled before taking it.
We’ve drafted a message you can send Preferred Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0518-2023 — Preferred Pharmaceuticals Preferred Pharmaceuticals Hello, I own a Preferred Pharmaceuticals that is covered by recall D-0518-2023 from Preferred Pharmaceuticals. 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.
