Class II · Moderate risk
Montelukast Sodium Tablets
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Montelukast Sodium Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Affected NDCs
68788-9438-03
68788-9438-06
68788-9438-09
Compare with the code on your package — it is the most precise check available.
Drug: Montelukast
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- NDC code
- 68788-9438-3
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0518-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Montelukast recalls
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Class II · Moderate risk
Montelukast Sodium USP
CGMP deviations.
Class III · Low risk
Montelukast Sodium Oral Granules USP
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Class II · Moderate risk
Montelukast Sodium Tablets
cGMP deviations
Class II · Moderate risk
Montelukast Sodium Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
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Class II · Moderate risk
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Class II · Moderate risk
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Class II · Moderate risk
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