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 Oral Granules
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Affected NDC
0378-6040-93
Compare with the code on your package — it is the most precise check available.
Drug: Montelukast
- Recalling firm
- Mylan Pharmaceuticals Inc.
- NDC code
- 0378-6040-93
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0920-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Montelukast recalls
See all
Class II · Moderate risk
Montelukast Sodium USP
CGMP deviations.
Class III · Low risk
Montelukast Sodium Oral Granules USP
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Class II · Moderate risk
Montelukast Sodium Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Montelukast Sodium Tablets
cGMP deviations
Other recalls by Mylan Pharmaceuticals Inc.
All 2017 recalls
Class II · Moderate risk
Carton label: Mycophenolate Mofetil for injection
Failed Dissolution Specifications
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Class II · Moderate risk
Acamprosate Calcium
Failed Dissolution Specifications
Class II · Moderate risk
Mycophenolate Mofetil for Injection USP
Presence of precipitate
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