FDA-Drug2020-02-05Class III
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
Macleods Pharma Usa Inc
Hazard
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Sold states
Nationwide within the United States
Affected count
10680 units
Manufactured in
666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0823-2020Don't want to check this manually?
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