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

Recall date

January 20, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0823-2020

FDA classification

Class III

Brand / firm

Macleods Pharma Usa Inc

Sold / distributed

Nationwide within the United States

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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