Drug 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
D-0823-2020
Product summary
- Event
- Event 84749
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10680 units
- Official record key
drug-enforcement:D-0823-2020
Official wording
Reason: Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Code information: Lot #: BMD8901B, Exp. Date 02/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
out of specification