FDA recall D-0032-2016

Ohm Laboratories, Inc. · Class III · drug

Product

Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5

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-0032-2016