FDA recall D-0823-2020

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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2020-01-20

Report date

2020-02-05

Termination date

2021-04-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0823-2020