14 FDA recalls mention Montelukast. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Montelukast.
Reason 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…
Reason CGMP deviations.
Reason Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Reason cGMP deviations
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Reason Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Reason Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Reason Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Reason Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Labeling: Label Mixup: MONTELUKAST SODIUM, CHEW Tablet, 4 mg may be potentially mislabeled as the following drug: DICYCLOMINE HCL, Tablet, 20 mg…
Reason Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they…
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