Class III
Terminated
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
- Company
- Macleods Pharma Usa Inc
- Recall Initiated
- January 20, 2020
- Posted
- February 5, 2020
- Recall Number
- D-0823-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10680 units
- Firm Location
- Plainsboro, NJ, United States
Reason for Recall
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: BMD8901B, Exp. Date 02/2021
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