Home / Recalls / Macleods Pharma Usa Inc / D-0823-2020

D-0823-2020 Class III Terminated

Recalled by Macleods Pharma Usa Inc — Plainsboro, NJ

Recall Details

Product Type
Drugs
Report Date
February 5, 2020
Initiation Date
January 20, 2020
Termination Date
April 26, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10680 units

Product Description

Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10

Reason for Recall

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

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: BMD8901B, Exp. Date 02/2021

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