Ohm Laboratories, Inc. recalls TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's 10-count tablets per box (NDC
Recalled October 21, 2015 · FDA recall D-0035-2016 · Ohm Laboratories
Hazard
Superpotent Drug: Out Of Specification (OOS) result for Assay. · FDA Class III
Units
53,688 boxes
Sold at
Nationwide.
Description
Superpotent Drug: Out Of Specification (OOS) result for Assay.
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.
Manufacturer(s)
Ohm Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →