FDA recall D-0035-2016

Ohm Laboratories, Inc. · Class III · drug

Product

TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC 36800-528-69, UPC 0 3680010261 3); and b) 10-count tablets per box, (NDC 36800-527-69, UPC 0 3680008395 0); Distributed by Topco Associates, LLC, Elk Grove Village, IL 60007.

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-0035-2016