Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9

Recall Number: D-0031-2016

Firm: Ohm Laboratories, Inc.

Classification: Class III

Status: Terminated

Report Date: 20151021

Initiation Date: 20150728

Termination Date: 20161028

Superpotent Drug: Out Of Specification (OOS) result for Assay.

Major loratadine orally disintegrating tablets, USP, 10 mg, 10-count tablets per box, Distributed by Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, USA, NDC 0904-5806-15, UPC 3 0904580615 9