FDA recall D-0027-2016

Ohm Laboratories, Inc. · Class III · drug

Product

Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) For kids 10-count tablets per box, NDC 24385-0161-52, ABC # 042-226, UPC 0 8770140650 8; b) For adults 10-count tablets, NDC 46122-0140-52, ABC# 059-535, UPC 0877014065546, Distributed by: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087

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-0027-2016