FDA recall D-0031-2016

Ohm Laboratories, Inc. · Class III · drug

Product

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

Reason for recall

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

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2015-07-28
Report date: 2015-10-21
Termination date: 2016-10-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: North Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0031-2016