Recall: D-0823-2020

Class III - Minor Violations

Class IIIClassification

2020-01-20Initiated

TerminatedStatus

Macleods Pharma Usa IncFirm

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

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

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.