Macleods Pharma Usa Inc recalls Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plain
Recalled February 5, 2020 · FDA recall D-0823-2020 · Macleods Pharma Usa
Hazard
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product · FDA Class III
Units
10680 units
Sold at
Nationwide within the United States
Description
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Product
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
Manufacturer(s)
Macleods Pharma Usa Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →