D-0510-2023 Class III Terminated
FDA drug recall D-0510-2023 was initiated by Teva Pharmaceuticals USA Inc on March 27, 2023 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A. The recall status is terminated (terminated August 23, 2023). Affected quantity: 3,772 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- April 12, 2023
- Initiation Date
- March 27, 2023
- Termination Date
- August 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,772 cartons
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Distribution Pattern
USA Nationwide
Code Information
Lot # 3007556A, Exp 5/2023