FDAClass IIIFebruary 5, 2020

Montelukast Sodium Chewable Tablets recall: Failed Dissolution

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

Why was Montelukast Sodium Chewable Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: BMD8901B, Exp. Date 02/2021

Product
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by…
Recalling firm
Macleods Pharma Usa Inc
Quantity
10680 units
Distribution
Nationwide within the United States
Recall date
February 5, 2020
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls