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FDAJuly 28, 2015drug

Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2

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

840986018992

Recall history

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

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