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FDAJuly 28, 2015drug

Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104

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

010939365446010939349446

Recall history

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

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