MONTELUKAST

Generic: MONTELUKAST

BluePoint LaboratoriesManufacturer

ORALRoute

MONTELUKAST SODIUMActive Substance

2014-09-11Original Approval

MONTELUKAST is FDA application ANDA203366, sponsored by MACLEODS PHARMS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2023-02-07

Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2018-08-20

Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadc

Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets

Class III2020-01-20

Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plain

Failed Dissolution Specifications: testing revealed low out of specification result in one lot of p

Class II2023-10-13

Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton,

Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodi

Class I2018-08-15

Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tab

Class III2017-01-07

Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,

Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spo

MONTELUKAST

Recalls

Top Reported Reactions