D-0823-2020 Class III Terminated
FDA drug recall D-0823-2020 was initiated by Macleods Pharma Usa Inc on January 20, 2020 and is designated Class III. Reason for recall: Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product The recall status is terminated (terminated April 26, 2021). Affected quantity: 10680 units.
Recall Details
- Product Type
- Drugs
- Report Date
- February 5, 2020
- Initiation Date
- January 20, 2020
- Termination Date
- April 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10680 units
Product Description
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
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: BMD8901B, Exp. Date 02/2021