Teva Pharmaceuticals USA Inc recalls Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Ph
Recalled April 12, 2023 · FDA recall D-0510-2023 · Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A. · FDA Class III
Units
3,772 cartons
Sold at
USA Nationwide
Description
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
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
Manufacturer(s)
Teva Pharmaceuticals USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →