FDA Drug Class III — Least Serious

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

Hazard

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

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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,
Brand
Macleods Pharma Usa Inc
UPC
Lot #: BMD8901B, Exp. Date 02/2021

Units Affected

10680 units

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