FDA-Drug2023-04-12Class III
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
Teva Pharmaceuticals USA Inc
Hazard
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Sold states
USA Nationwide
Affected count
3,772 cartons
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0510-2023Don't want to check this manually?
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