Drug product
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
D-0510-2023
Product summary
- Event
- Event 91958
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,772 cartons
- Official record key
drug-enforcement:D-0510-2023
Official wording
Reason: Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Code information: Lot # 3007556A, Exp 5/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications