Drug 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
Lots and codes
Lot #: BMD8901B, Exp. Date 02/2021
Recall details
- Recalling firm
- Macleods Pharma Usa Inc, Plainsboro, NJ
- Quantity
- 10680 units
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 20, 2020
- Terminated
- April 26, 2021
Related products
- Montelukast Sodium – drug information
- NDC 33342-111 Montelukast sodium · Montelukast 5 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-110 Montelukast sodium · Montelukast 4 mg/1 · Macleods Pharmaceuticals Limited