Class III
Terminated
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
- Company
- Teva Pharmaceuticals Usa, Inc
- Recall Initiated
- March 27, 2023
- Posted
- April 12, 2023
- Recall Number
- D-0510-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,772 cartons
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Distribution
USA Nationwide
Lot / Code Info
Lot # 3007556A, Exp 5/2023
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