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FDAJuly 28, 2015drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

ohm laboratoriesohm

UPCs

036800102613036800083950

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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