FDA recall D-0510-2023

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

Reason for recall

Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2023-03-27

Report date

2023-04-12

Termination date

2023-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0510-2023