US Drug Recall Register
Class III · Low risk Terminated Initiated Jul 28, 2015 (11 years ago)

TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg, packaged in a) Children's…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

What was recalled

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.

Recalling firm
Ohm Laboratories, Inc.
NDC code
36800-528-69
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0035-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.